122

Jobs in Puerto Rico

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122 Jobs in Puerto Rico


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Engineer

Qrc Group, Llc - Juncos - Puerto Rico
2 years
Not Disclosed
Puerto Rico / 2 / Negotiable

Engineer with experience in GMP Biotech environment, to provide solutions to a variety of technical problems of moderate scope and complexity. Responsibilities:Evaluate, select and apply standard engineering techniques and proceduresAssistance given for unusual problemsInvestigation of limited number of variablesInitiate and complete routine technical tasksTroubleshooting operationsRoutinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity. Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.1st shift (OT will be based on business needs)RequirementsMaster s or Bachelor s degree in Chemical Engineering & 2 years of engineering experienceBilingual (Spanish/English)Computer literacyTechnical writing1st shift (OT will be based on business needs) Master s or Bachelor s degree in Chemical Engineering & 2 years of engineering experience Bilingual (Spanish/English) Computer literacy Technical writing 1st shift (OT will be based on business needs) Less

Engineer with experience in GMP Biotech environment, to provide solutions to a variety of technical problems of moderate scope and complexity. Responsibilities:Evaluate, select and apply standard engineering techniques and proceduresAssistance given for unusual problemsInvestigation of limited number of variablesInitiate and complete routine techni More..

Sr. Financial Analyst

Prpdg - others - Puerto Rico
Not Specified
Not Disclosed
Puerto Rico / Not Specified / Negotiable

Description Leads the integration of the Sarbanes and Oxley Law efforts implementation to assure compliance with all legal aspects on company policies procedures and acceptable accounting legal practices. Examines financial statements and documents for conformance with accounting/finance requirements and principles. Serves as a Parent Inter Company and Auditors liaison. Requirements Bachelor Degree in Accounting or Finance, MBA and/or CPA preferred. Experience Eight years or more experience in General Accounting, Operations Accounting and/or related functions within a manufacturing environment. Fully bilingual (English/Spanish, read, write and speak). Excellent interpersonal relations. Ability to work under pressure. Less

Description Leads the integration of the Sarbanes and Oxley Law efforts implementation to assure compliance with all legal aspects on company policies procedures and acceptable accounting legal practices. Examines financial statements and documents for conformance with accounting/finance requirements and principles. Serves as a Parent Inter Compan More..

Specialist Qa

Not Specified
Not Disclosed
Puerto Rico / Not Specified / Negotiable

Description:Perform one or more of the following duties and responsibilities in support of site Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.EDUCATION: Doctorate degree or Masters degree and 3 years of directly related experience or Bachelors degree and 5 years of directly related experience or Associates degree and 10 years of directly related experience.FUNCTIONS Responsible for providing Quality oversight to ensure that operations for licensed pharmaceutical products are manufactured, tested, and stored, according to current Good Manufacturing Practices (cGMP) and other applicable regulations. Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations. Review and approval of Electronic Batch Records and related documentation to support Drug Substance Disposition Process. Performs SAP systems transactions to support batch processing and disposition requirements. Data entry, review and approval of LIMS sample test results to support batch processing and disposition requirements. Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformance s, CAPAs, and validations Supports Continual Improvement initiatives, programs and projects Ensures that deviations from established procedures are investigated and documented per procedures Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures Alerts senior management of quality, compliance, supply and safety risks Represents the quality unit during audits and inspections as needed Completes required assigned training to permit execution of required tasks Performs additional duties as specified by managementPREFERRED QUALIFICATION Project management skills Strong organizational skills, including ability to follow assignments through to completion Initiate and lead cross functional teams Enhanced skills in leading, influencing and negotiating Strong knowledge in area of expertise Collaborate and coordinate with higher level outside resources Strong knowledge of and experience with processes involved in manufacturing, QA, QC, validation and process development Demonstrate ability to interact with regulatory agenciesCOMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation. Ability to evaluate compliance issues, Demonstrate site Values/Leadership Practices. Less

Description:Perform one or more of the following duties and responsibilities in support of site Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Re More..

Operations Clerk

Qrc Group, Llc - caguas - Puerto Rico
2 years
Not Disclosed
Puerto Rico / 2 / Negotiable

Operations Clerk with previous experience in a regulated industry (medical device, electronics or pharmaceutical).Responsibilities:Calculate, materials reconciliation, discrepancies detect, evaluate, documentation inspections and collect data. Responsible to execute the material/labor confirmation process for all assigned manufacturing operations.Assure open work orders quantity comply Investigate and perform corrective action, once have been approved by supervisor and/or managementConduct inventory and report results to management.RequirementsAssociate Degree Business Administration and 2 years of experienceBilingual (Spanish/English)(Written/Spoken)Computer skills Associate Degree Business Administration and 2 years of experience Bilingual (Spanish/English)(Written/Spoken) Computer skills Less

Operations Clerk with previous experience in a regulated industry (medical device, electronics or pharmaceutical).Responsibilities:Calculate, materials reconciliation, discrepancies detect, evaluate, documentation inspections and collect data. Responsible to execute the material/labor confirmation process for all assigned manufacturing operations.A More..

Qa Technician

1 Year
Not Disclosed
Puerto Rico / 1 / Negotiable

QA Technicianwith experience in regulated industries.Responsibilities:Assures the quality of manufactured products and processes per standard operating processes(SOPS) and GMP (Good Manufacturing Practices).Availability to work 2nd and 3rd shift.RequirementsAssociate Degreein Science and 1 year of previous experience in similar role/industryProficiency in English/Spanish (oral and written)Availability to work at 2nd. & 3rd. shift AD and 1 year of related experience Less

QA Technicianwith experience in regulated industries.Responsibilities:Assures the quality of manufactured products and processes per standard operating processes(SOPS) and GMP (Good Manufacturing Practices).Availability to work 2nd and 3rd shift.RequirementsAssociate Degreein Science and 1 year of previous experience in similar role/industryProfici More..

Sr Validation Scientist

Qrc Group, Llc - Juncos - Puerto Rico
5 years
Not Disclosed
Puerto Rico / 5 / Negotiable

Sr Validation Scientist with robust knowledge and execution of Good Manufacturing Procedures. Experience working in regulatory industries toprovides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.Troubleshoot systemic validation issues.Validation engineering principlesChange Control, Trackwise and Equipment Interphase (HMIs) systemsCleaning Validation Execution, Develop Protocols, Technical Reports, Validation Summary Reports and Validation Master PlansGMP production operationsDocumentationAvailable to work: 1st shift, 8am to 5pm, 80% of time, non-administrative shift, (2nd/3rd or weekend duty) to support execution of validation studies, 20% of timeRequirementsMasters degree and 3 years of directly related experience or Bachelors degree and5 years of directly related experience or Associates degree and 10 years of directly related experienceFDA regulationsTechnical writing and presentation skills.Project management skills.Excellent written and oral communication skills in English and Spanish (Bilingual)Available to work: 1st shift, 8am to 5pm, 80% of time, non-administrative shift, (2nd/3rd or weekend duty) to support execution of validation studies, 20% of time Master\'s degree and 3 years of directly related experience or Bachelor\'s degree and 5 years of directly related experience or Associate\'s degree and 10 years of directly related experience FDA regulations Technical writing and presentation skills. Project management skills. Excellent written and oral communication skills in English and Spanish (Bilingual) Available to work: 1st shift, 8am to 5pm, 80% of time, non-administrative shift, (2nd/3rd or weekend duty) to support execution of validation studies, 20% of time Less

Sr Validation Scientist with robust knowledge and execution of Good Manufacturing Procedures. Experience working in regulatory industries toprovides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.T More..

Specialist Qa

Qrc Group, Llc - Juncos - Puerto Rico
5 years
Not Disclosed
Puerto Rico / 5 / Negotiable

Specialist QA with experience in Pharmaceutical GMP manufacturing.Functions:Product MPs.Environmental Characterization reports.Sanitary utility systems.Represent QA on NPI team.Investigations.Site audits.Risk Assessments.Automation activities.Facilities and environmental programs.Work Orders.CAPAChange controls.Lot disposition and authorize lots for shipment.RequirementsDoctorate or Master degree and 3 years of directly related experience or Bachelor degree and 5 years of directly related experience or Associates degree and 10 years of directly relatedBilingual (Spanish/English)(Written/Spoken)Technical writingComputer literacy Doctorate or Master degree and 3 years of directly related experience or Bachelor degree and 5 years of directly related experience or Associates degree and 10 years of directly related Bilingual (Spanish/English)(Written/Spoken) Technical writing Computer literacy Less

Specialist QA with experience in Pharmaceutical GMP manufacturing.Functions:Product MPs.Environmental Characterization reports.Sanitary utility systems.Represent QA on NPI team.Investigations.Site audits.Risk Assessments.Automation activities.Facilities and environmental programs.Work Orders.CAPAChange controls.Lot disposition and authorize lots fo More..

Process Development Principal Scientist

Qrc Group, Llc - Juncos - Puerto Rico
8 years
Not Disclosed
Puerto Rico / 8 / Negotiable

Process Development Principal Scientist with working knowledge of pharmaceutical/biotech processes.Experience managing projects and decommissioning activities. Broad knowledge in change control process and QMTS. Knowledge in business case process.RequirementsDoctorate degree and 3 years of experience or Master s degree and 6 years of experienceor Bachelor s degree and 8 years of experienceBackground in Science or Engineering with experience in manufacturing, validation or process developmentWorking knowledge of financial analysis toolsSkills in the following areas: Negotiation, persuasion and facilitation, Collaboration, Project cost development, Conflict Resolution Management of contractors and vendorsKnowledge of theories and principles related to leading edge technologiesAdvanced (industry level) technical expert in at least one specialty areaAdvanced project managementBilingual (Spanish/English)Computer literacy Doctorate degree and 3 years of experience or Master s degree and 6 years of experience or Bachelor s degree and 8 years of experience Background in Science or Engineering with experience in manufacturing, validation or process development Working knowledge of financial analysis tools Skills in the following areas: Negotiation, persuasion and facilitation, Collaboration, Project cost development, Conflict Resolution Management of contractors and vendors Knowledge of theories and principles related to leading edge technologies Advanced (industry level) technical expert in at least one specialty area Advanced project management Bilingual (Spanish/English) Computer literacy Less

Process Development Principal Scientist with working knowledge of pharmaceutical/biotech processes.Experience managing projects and decommissioning activities. Broad knowledge in change control process and QMTS. Knowledge in business case process.RequirementsDoctorate degree and 3 years of experience or Master s degree and 6 years of experienceor More..

Online German (daf) Teacher

Lingoda - san juan - Puerto Rico
Not Specified
Not Disclosed
Puerto Rico / Not Specified / Negotiable

Are you looking for the perfect, flexible job that works around travelling, university or family commitments? Would you like to work with modern learning materials and focus on interactive teaching? Are you tired of traditional textbooks, homework correction and long preparation times? If the answer to all of the above is yes, we would love to get to know you! About Lingoda: As the #1 trusted online language school, Lingoda is a leading online learning platform. With over 10,000 classes happening per week across four different languages we drive to deliver the best possible educational experience for teachers and students alike. By joining Lingoda you are joining a rapidly growing team that represents the future of language learning. Tasks Your skills and experience: Native-level German language skills ( C2+) You have at least 1 year s experience in teaching German You have a degree in DaF / DaZ or related courses (German Studies, Lehramt Deutsch, Linguistics, Translation) You are driven, self-organized and tech-savvy Requirements Technical equipment (High speed internet connection, headset with microphone, Laptop/desktop with a camera) Comfortable quiet working environment You can legally work as a freelancer Benefits All teaching materials are available from Lingoda Flexible working hours - you design your own schedule! Motivated adult learners No minimum weekly teaching hours Work remotely from anywhere in the world 25% off on all of our language courses International atmosphere: teach students from all over the world Be part of the future of language learning! If this sounds interesting to you, we would love to receive your application on our official page "lingoda become a teacher". We look forward to meeting you virtually! :) Less

Are you looking for the perfect, flexible job that works around travelling, university or family commitments? Would you like to work with modern learning materials and focus on interactive teaching? Are you tired of traditional textbooks, homework correction and long preparation times? If the answer to all of the above is yes, we would love to get More..

Sr Automation Engineer

Qrc Group, Llc - Juncos - Puerto Rico
5 years
Not Disclosed
Puerto Rico / 5 / Negotiable

Sr Automation Engineer withexperience in Pharmaceutical manufacturing automation systems maintenance and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects.With knowledge in:Validation activitiesRockwell Automation systems (ControlLogix, RSView, RSBatch, Communication Network (CNet\DNet\Ethernet) preferred.ASTM 2500, ISA S88 and S95 standards.OSI PI Historian (PI ProcessBook, BatchView and Datalink)Troubleshooting experience with Automation systems is desiredTroubleshooting experience with Cell Culture/Purification process/systems is desiredPrograming language (e.g. VBA)Data integrity knowledge and applicationISA Certified Automation ProfessionalRequirementsMaster degree in Engineering and 3 years of experience in the Pharmaceutical or Biotechnology industries or Bachelor degree in Engineering and 5 years of experience in the Pharmaceutical or Biotechnology industriesSoftware requirement: Rockwell Software PlatformKnowledge and used of system as MAXIMO, TrackwiseBilingual (Spanish/English) Master degree in Engineering and 3 years of experience in the Pharmaceutical or Biotechnology industries or Bachelor degree in Engineering and 5 years of experience in the Pharmaceutical or Biotechnology industries Software requirement: Rockwell Software Platform Knowledge and used of system as MAXIMO, Trackwise Bilingual (Spanish/English) Less

Sr Automation Engineer withexperience in Pharmaceutical manufacturing automation systems maintenance and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies. Applies advanced and diverse engineering principles to the design and implementation o More..

Sr Validation Scientist

Qrc Group, Llc - Juncos - Puerto Rico
5 years
Not Disclosed
Puerto Rico / 5 / Negotiable

Sr Validation Specialist with experience in regulated industry to independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.Responsibilities:Commissioning and qualification of drug substance equipment such as tanks, bioreactors, computerized systems and analytical equipment, facilities, and utilities.Read a P and ID drawing.C and Q plan systems URS, Risk Assessments, and vendors documentation.Elaborate, handling and execute a testing protocol including the resolution of deviations.Handle a GMP document.Interact with system vendors during preparatory C and Q activitiesParticipate when a problem resolution requires C and Q team members provide guidanceRequirementsDoctorate or Masters degree and 3 years of directly related experience or Bachelors degree and 5 years of directly related experience or Associates degree and 10 years of directly related experienceBilingual (Spanish/English)(Written/Spoken)Computer SkillsTechnical WritingAdvanced validation knowledge (equipment qualification, cleaning, sterilization). Doctorate or Master\'s degree and 3 years of directly related experience or Bachelor\'s degree and 5 years of directly related experience or Associate\'s degree and 10 years of directly related experience Bilingual (Spanish/English)(Written/Spoken) Computer Skills Technical Writing Advanced validation knowledge (equipment qualification, cleaning, sterilization). Less

Sr Validation Specialist with experience in regulated industry to independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.Responsibilities:Commissioning and qualification of drug subs More..

Qa Technician

Qrc Group, Llc - arecibo - Puerto Rico
1 Year
Not Disclosed
Puerto Rico / 1 / Negotiable

QA Technicianwith experience in regulated industries, pharmaceutical or medical devices.Responsibilities:Assures the quality of manufactured products and processes per standard operating processes (SOPS) and GMP (Good Manufacturing Practices).This position has Non-Standard Shift.RequirementsHigh School diploma and 1 year of previous experience in similar role/industryProficiency in English/Spanish (oral and written)Available to work any shift (1st,2nd,3rd) High School diploma and 1 year of previous experience in similar role/industry Proficiency in English/Spanish (oral and written) Available to work any shift (1st,2nd,3rd) Less

QA Technicianwith experience in regulated industries, pharmaceutical or medical devices.Responsibilities:Assures the quality of manufactured products and processes per standard operating processes (SOPS) and GMP (Good Manufacturing Practices).This position has Non-Standard Shift.RequirementsHigh School diploma and 1 year of previous experience in s More..

Engineer

Qrc Group, Llc - Juncos - Puerto Rico
2 years
Not Disclosed
Puerto Rico / 2 / Negotiable

Engineer with experience in GMP Biotech environment, to provide solutions to a variety of technical problems of moderate scope and complexity. Responsibilities:Evaluate, select and apply standard engineering techniques and proceduresAssistance given for unusual problemsInvestigation of limited number of variablesInitiate and complete routine technical tasksTroubleshooting operationsRoutinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity. Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.1st shift (OT will be based on business needs)RequirementsMaster s or Bachelor s degree in Chemical Engineering & 2 years of engineering experienceBilingual (Spanish/English0Computer literacyTechnical writing1st shift (OT will be based on business needs) Master s or Bachelor s degree in Chemical Engineering & 2 years of engineering experience Bilingual (Spanish/English0 Computer literacy Technical writing 1st shift (OT will be based on business needs) Less

Engineer with experience in GMP Biotech environment, to provide solutions to a variety of technical problems of moderate scope and complexity. Responsibilities:Evaluate, select and apply standard engineering techniques and proceduresAssistance given for unusual problemsInvestigation of limited number of variablesInitiate and complete routine techni More..

Qa Technician

Qrc Group, Llc - caguas - Puerto Rico
1 Year
Not Disclosed
Puerto Rico / 1 / Negotiable

QA Technicianwith experience in regulated industries, pharmaceutical or medical devices.Responsibilities:Assures the quality of manufactured products and processes per standard operating processes (SOPS) and GMP (Good Manufacturing Practices).This position has Non-Standard Shift.RequirementsHigh School diploma and 1 year of previous experience in similar role/industryProficiency in English/Spanish (oral and written)Available to work any shift (1st,2nd,3rd) High School diploma and 1 year of previous experience in similar role/industry Proficiency in English/Spanish (oral and written) Available to work any shift (1st,2nd,3rd) Less

QA Technicianwith experience in regulated industries, pharmaceutical or medical devices.Responsibilities:Assures the quality of manufactured products and processes per standard operating processes (SOPS) and GMP (Good Manufacturing Practices).This position has Non-Standard Shift.RequirementsHigh School diploma and 1 year of previous experience in s More..

Project Manager

Qrc Group, Llc - Juncos - Puerto Rico
4 years
Not Disclosed
Puerto Rico / 4 / Negotiable

Project Mananger with experience in regulated industry to oversee, manage and coordinate all operational aspects of ongoing department projects impacting multiple departments. Serves as liaison between project team and department.Responsibilities:Work closely with Supply Chain Operations and Planning teams to ensure product and material requirements are managed.Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.Create, analyze, and present metrics.Establish and achieves project standards for work quality and quantity.Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.Assist in technical, financial, and organizational issues by researching issues, providing recommendations and maintaining document archives.Maintain and track project budget(s).Reconcile the use of resources for the projects.Identify and anticipate schedule slips or changes and analyzes the costs and resource impact.Implement tools, techniques and processes to provide or create information to enable informed decision-making within the teams.Liaison with department staff, sub or satellite team leaders and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project.Maintain the master project plan and schedule for assigned projects.Identify or lead focus area projects within the overall function of project management or related projects.Generate periodic updates and prepare formal presentations for required forums.Generate individual and more complex reports utilizing various resources.Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.Ensure project work complies with practices, policies and standard operating procedures.RequirementsDoctorate or Masters degree and 2 years of Project Management experience or Bachelors degree and 4 years of Project Management experience or Associate s degree and 10 years of Project ManagementBilingual (Spanish/English)(Written/Spoken)Technical WritingComputer skills (Trackwise, SAP, EDW, Excel, Word, Power Point, Smartsheet and other analytics software)Experience with audits and regulatory agencies Doctorate or Master\'s degree and 2 years of Project Management experience or Bachelor\'s degree and 4 years of Project Management experience or Associate s degree and 10 years of Project Management Biingual (Spanish/English)(Written/Spoken) Technical Writing Computer skills (Trackwise, SAP, EDW, Excel, Word, Power Point, Smartsheet and other analytics software) Experience with audits and regulatory agencies Less

Project Mananger with experience in regulated industry to oversee, manage and coordinate all operational aspects of ongoing department projects impacting multiple departments. Serves as liaison between project team and department.Responsibilities:Work closely with Supply Chain Operations and Planning teams to ensure product and material requirement More..

Quality Assurance Specialist

Qrc Group, Llc - caguas - Puerto Rico
Not Specified
Not Disclosed
Puerto Rico / Not Specified / Negotiable

Quality Assurance Specialist with experience in regulated industry to ensure compliance based on applicable regulations (e.g., FDA), policies and procedures. Align local Policies and Procedures with ADC Division and assure full compliance with local regulations.Work with the different Affiliate departments, such as Commercial, ADC Division, and other divisions on the development and maintenance of the Quality Management System (QMS), including: Quality Manual, Org Chart, Job Descriptions, Policies and Procedures, Document Management, Training Management, Training Plans, Training Compliance, Supplier Management File (SMF), Authorization for Shipment (AFS) and CAPA - Corrective Action / Preventive Action.Responsibilities:Follow applicable Quality Standards.Proven data collection, management and analysis. Problem analysis and problem solving. Customer service driven.RequirementsBachelor degree in Engineering or Science with minimum of 3 yearsof relevant experience in a regulated environment ISO 13485 certificateFDA 21 CFR 820 certificate Lean Six Sigma Green Belt certificationBilingual (English/Spanish)(Verbal and Written)Microsoft Office Bachelor degree in Engineering or Science with minimum of 3 years of relevant experience in a regulated environment ISO 13485 certificate FDA 21 CFR 820 certificate Lean Six Sigma Green Belt certification Bilingual (English/Spanish)(Verbal and Written) Microsoft Office Less

Quality Assurance Specialist with experience in regulated industry to ensure compliance based on applicable regulations (e.g., FDA), policies and procedures. Align local Policies and Procedures with ADC Division and assure full compliance with local regulations.Work with the different Affiliate departments, such as Commercial, ADC Division, and oth More..

Sr Validation Scientist

Qrc Group, Llc - Juncos - Puerto Rico
5 years
Not Disclosed
Puerto Rico / 5 / Negotiable

Sr Validation Scientist with experience in utilities validation, facilities and critical systems qualification, Controlled Temperature Chambers (CTC), Controlled Room Temperature (CRT), Validation, validation lifecycle documents Validation protocol generation and execution, commissioning and qualification process, IQ,/OQ/PQ process.Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects.Develop validation engineering policies and procedures that affect multiple organizational units.Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.RequirementsDoctorate or Master s degree and 3 years of directly related experience or Bachelor s degree and 5 years of directly related experience orAssociate s degree and 10 years of directly related experience.Bilingual (Spanish/English)Technical writingAdvanced validation knowledge (equipment qualification, cleaning, sterilization).Applies extensive technical validation expertise, and has full knowledge of other related disciplines.Regular first shift but will support of hours activities as required by specific project schedules. Doctorate or Master s degree and 3 years of directly related experience or Bachelor s degree and 5 years of directly related experience or Associate s degree and 10 years of directly related experience. Bilingual (Spanish/English) Technical writing Advanced validation knowledge (equipment qualification, cleaning, sterilization). Applies extensive technical validation expertise, and has full knowledge of other related disciplines. Regular first shift (8 hrs) but will support off hours activities as required by specific project schedules. Less

Sr Validation Scientist with experience in utilities validation, facilities and critical systems qualification, Controlled Temperature Chambers (CTC), Controlled Room Temperature (CRT), Validation, validation lifecycle documents Validation protocol generation and execution, commissioning and qualification process, IQ,/OQ/PQ process.Applies advanced More..

Sr Validation Scientist

Qrc Group, Llc - Juncos - Puerto Rico
5 years
Not Disclosed
Puerto Rico / 5 / Negotiable

Sr Validation Scientist with experience in commissioning and qualification, computer validation (CSV).Provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.Able to troubleshoot systemic validation issues.Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects.Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity.Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures.Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise.Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.RequirementsDoctorate or Masters degree and 3 years of directly related experience or Bachelors degree and 5 years of directly related experience in Science or Engineering or Associates degree and 10 years of directly related experience.Bilingual (Spanish/English)Technical writing Doctorate or Master\'s degree and 3 years of directly related experience or Bachelor\'s degree and 5 years of directly related experience in Science or Engineering or Associate\'s degree and 10 years of directly related experience. Bilingual (Spanish/English) Technical writing Less

Sr Validation Scientist with experience in commissioning and qualification, computer validation (CSV).Provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.Able to troubleshoot systemic validatio More..

Amazon Listing Content Writer (remote)

Not Specified
Not Disclosed
Puerto Rico / Not Specified / Negotiable

Candidate must be residing in Puerto Rico and have Prior Amazon Listing content writing experience.You will also be creating and managing written content for listing optimizations, EBC/A+ content, product posts, and overseeing all aspects of keyword research and implementation. You will have direct input for listing written content along with the terminology used on graphic assets to increase sales, and support Amazon advertising efforts. You will be the one to shape and showcase products for multi-million dollar brands.Your content should capture the attention of Amazon shoppers, differentiate us from our competition, and always communicate the right brand message. For this, you need to have enthusiasm, creative drive, a competitive edge to get the click and win the sale with your content! Amazon Listings Content Writer Job Duties:Write clear, impactful, informative content that will win the saleDevelop content based on the individual products specs and target audienceCollaborate with designers, account managers, and marketing teamsUse Amazon SEO principles to maximize listings reachBe the Amazon terminology expert, knowledgeable with term restrictions by categoryAdvanced Keyword trend research and managementFrequent audits, edits, updatesUpdate and maintain product optimization trackerUnderstand and manage seasonality content for listings Less

Candidate must be residing in Puerto Rico and have Prior Amazon Listing content writing experience.You will also be creating and managing written content for listing optimizations, EBC/A+ content, product posts, and overseeing all aspects of keyword research and implementation. You will have direct input for listing written content along with the t More..

Engineer

Qrc Group, Llc - Juncos - Puerto Rico
2 years
Not Disclosed
Puerto Rico / 2 / Negotiable

Engineer with experience in manufacturing of bio-processes to bring operations support and applicable execution of manufacturing/quality systems such as design of operations and system requirements, procedures, deviation investigations, process monitoring, training, and new product introductions. Organizes, analyzes and presents interpretation of results for operational issues or projects.Responsibilities:Routinely monitor manufacturing processes. Suggest problem resolution and provide troubleshooting guidance. Assess observations from floor operations and gather and analyze data to identify root cause and implement solutions for process improvement opportunities.Function as a technical expert to process or systems regarding troubleshooting operations.Participate in the New Product Introductions (NPI) NPI to assess requirements for documentation, materials, training, and equipment modifications.Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.Initiate, revise, and approve manufacturing controlled documents in the Document Management System . Ensure all manufacturing controlled documents reflect current operations. Serve as a document author, owner, reviewer, or data verified, as needed.Perform deviations assessments and support deviation lead during the root cause, human performance evaluation, CAPA development, and closure of record within established goal.Monitor effectiveness of CAPA implemented to prevent recurrence of deviation. RequirementsMaster s or Bachelor s degree in Engineer and 2 years of engineering experienceBilingual (Spanish/English)Skilled in performance of GMP production operationsRegulatory knowledge and interactionsOrganizational, technical writing and presentation skills.Project management skillsKnowledge of control charting and basic statistics Master s or Bachelor s degree in Engineer and 2 years of engineering experience Bilingual (Spanish/English) Skilled in performance of GMP production operations Regulatory knowledge and interactions Organizational, technical writing and presentation skills. Project management skills Knowledge of control charting and basic statistics Less

Engineer with experience in manufacturing of bio-processes to bring operations support and applicable execution of manufacturing/quality systems such as design of operations and system requirements, procedures, deviation investigations, process monitoring, training, and new product introductions. Organizes, analyzes and presents interpretation of r More..