Integrated Services For Productivity & Validation, Inc

EW Specialist QA Job Description: SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Perform On-the-floor Plant Quality Assurance (PQA) review approval and tracking of cGMP processes procedures testing methods in manufacturing documents and records batch record review MES EBR

EW Specialist QA Job Description: SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Perform On-the-floor Plant Quality Assurance (PQA) review approval and tracking of cGMP processes procedures testing methods in manufacturing documents and records batch record review MES EBR

. Manufacturing Equipment ownership at CMMS system (Work orders approval closing PM strategy spare parts definition/accuracy/updates) reliability and change control assessments and requirements. Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturin

. Manufacturing Equipment ownership at CMMS system (Work orders approval closing PM strategy spare parts definition/accuracy/updates) reliability and change control assessments and requirements. Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturin

In this vital role you will provide technical engineering support to continuous daily operations by performing troubleshooting activities process optimization strategiesupgrades replacements and modifications to the process or equipment in the manufacturing operations.Ensure that all

In this vital role you will provide technical engineering support to continuous daily operations by performing troubleshooting activities process optimization strategiesupgrades replacements and modifications to the process or equipment in the manufacturing operations.Ensure that all

Experience working in a GMP-regulated environment within the pharmaceutical medical device or biotechnology industryProficiency in technical report writingEffective communication skills in both Spanish and English (verbal and written)Familiarity with packaging equipment process charac

Experience working in a GMP-regulated environment within the pharmaceutical medical device or biotechnology industryProficiency in technical report writingEffective communication skills in both Spanish and English (verbal and written)Familiarity with packaging equipment process charac

1. Direct experience providing technical or process-development support to commercial pharmaceutical biotechnology medical-device or combination-product manufacturing operations.2. Experience managing projects3. Experience with sterile injectable products prefilled syringes auto injec

1. Direct experience providing technical or process-development support to commercial pharmaceutical biotechnology medical-device or combination-product manufacturing operations.2. Experience managing projects3. Experience with sterile injectable products prefilled syringes auto injec

Preferred qualifications include experience with data analysis dashboard development statistical evaluation GMP documentation validation principles and process improvement. A standout candidate would have working knowledge of AI-enabled or automation tools such as Python Codex Power A

Preferred qualifications include experience with data analysis dashboard development statistical evaluation GMP documentation validation principles and process improvement. A standout candidate would have working knowledge of AI-enabled or automation tools such as Python Codex Power A

Facilities and Utilities Commissioning and QualificationComputer System ValidationEquipment validationRisk AssessmentsKNEATCDOCS SCADA TRACKWISEMAXIMOGood Documentation Practices Data IntegrityChange ControlsStandard Operation ProcedureSyringe/Vials Inspection ProcessDocuments revisio

Facilities and Utilities Commissioning and QualificationComputer System ValidationEquipment validationRisk AssessmentsKNEATCDOCS SCADA TRACKWISEMAXIMOGood Documentation Practices Data IntegrityChange ControlsStandard Operation ProcedureSyringe/Vials Inspection ProcessDocuments revisio

Experience in recipe entry in packaging equipment automation assessment to determine the correct parameter for the recipe and experience in Systech SystemRequirementsMasters degree OR Bachelors degree and 2 years of Engineering experience ORAssociates degree and 6 years of Engineering

Experience in recipe entry in packaging equipment automation assessment to determine the correct parameter for the recipe and experience in Systech SystemRequirementsMasters degree OR Bachelors degree and 2 years of Engineering experience ORAssociates degree and 6 years of Engineering

Previous experience in change control management project controls and capital projects. Demonstrated experience leading New Product Introduction (NPI) technology transfer process development lifecycle management or commercialization programs. Proven ability to lead complex cross-funct

Previous experience in change control management project controls and capital projects. Demonstrated experience leading New Product Introduction (NPI) technology transfer process development lifecycle management or commercialization programs. Proven ability to lead complex cross-funct

Strong knowledge and demonstrated experience with Quality Systems particularly deviations CAPA management Change Controls and controlled documentation. Some Experience supporting OEFM electronic forms or similar electronic quality and facilities-management systems preferred. Some und

Strong knowledge and demonstrated experience with Quality Systems particularly deviations CAPA management Change Controls and controlled documentation. Some Experience supporting OEFM electronic forms or similar electronic quality and facilities-management systems preferred. Some und

The position is responsible for supporting Quality and Manufacturing operations through accurate Batch Record Review documentation compliance electronic systems management inventory control and timely operational decision-making. The role requires a strong understanding of GMP require

The position is responsible for supporting Quality and Manufacturing operations through accurate Batch Record Review documentation compliance electronic systems management inventory control and timely operational decision-making. The role requires a strong understanding of GMP require

Manufacturing Operation experience (not quality)Document Management create new documents review and approval of documents. This resource must work with manufacturing operatorsRequirements-Doctorate OR Masters 2 years of Manufacturing Operations experience OR-Bachelors 4 years of Man

Manufacturing Operation experience (not quality)Document Management create new documents review and approval of documents. This resource must work with manufacturing operatorsRequirements-Doctorate OR Masters 2 years of Manufacturing Operations experience OR-Bachelors 4 years of Man

Skills in handling multiple responsibilities priorities tasks and projects simultaneously. Skills in working under time pressure. Practical project management software and spreadsheet skills proficient computer operation skills. Effective interactions in a team or matrixes environmen

Skills in handling multiple responsibilities priorities tasks and projects simultaneously. Skills in working under time pressure. Practical project management software and spreadsheet skills proficient computer operation skills. Effective interactions in a team or matrixes environmen

- Skills in handling multiple responsibilities priorities tasks and projects simultaneously. Skills in working under time pressure. Practical project management software and spreadsheet skills proficient computer operation skills. Effective interactions in a team or matrixs environmen

- Skills in handling multiple responsibilities priorities tasks and projects simultaneously. Skills in working under time pressure. Practical project management software and spreadsheet skills proficient computer operation skills. Effective interactions in a team or matrixs environmen

1. C&Q Strategy & Planning Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. Define system boundaries and identify direct/indirect impact systems. Lead risk assessments (e.g. ISPE Baseline ASTM E2500) to determin

1. C&Q Strategy & Planning Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. Define system boundaries and identify direct/indirect impact systems. Lead risk assessments (e.g. ISPE Baseline ASTM E2500) to determin

o Knowledge in document handling on Veeva Vault (CDOCs) or similar platformso Technical writing expertiseo Change control handling (owner)o Project handlingo Use of Smartsheet or similar platformRequirements-Doctorate OR Masters 2 years of Manufacturing Operations experience OR-Bache

o Knowledge in document handling on Veeva Vault (CDOCs) or similar platformso Technical writing expertiseo Change control handling (owner)o Project handlingo Use of Smartsheet or similar platformRequirements-Doctorate OR Masters 2 years of Manufacturing Operations experience OR-Bache

Perform On-the-floor Plant Quality Assurance (PQA) review approval and tracking of cGMP processes procedures testing methods in manufacturing documents and records batch record review MES EBR SAP EDMQ DQMS Trackwise; including but not limited to deviations CAPAs and validations. Acti

Perform On-the-floor Plant Quality Assurance (PQA) review approval and tracking of cGMP processes procedures testing methods in manufacturing documents and records batch record review MES EBR SAP EDMQ DQMS Trackwise; including but not limited to deviations CAPAs and validations. Acti

Initiate revise and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. Assess process performance by observation of floor operations and review of performance data. Evaluate plan and implement solutions for process improveme

Initiate revise and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. Assess process performance by observation of floor operations and review of performance data. Evaluate plan and implement solutions for process improveme

Bachelors degree in Engineering and 5 years of Engineering experience Knowledge in Packaging equipment. Knowledge in Design of new equipment process. Knowledge in Engineering Project Knowledge in Validations Experience in Medical Device or Pharma Bilingual (English/Spanish)Requirement

Bachelors degree in Engineering and 5 years of Engineering experience Knowledge in Packaging equipment. Knowledge in Design of new equipment process. Knowledge in Engineering Project Knowledge in Validations Experience in Medical Device or Pharma Bilingual (English/Spanish)Requirement

The ideal candidate should demonstrate a strong combination of technical analytical and operational skills to support AI-enabled optimization resource planning and validation-related initiatives within Drug Product.A standout candidate would have experience or demonstrated capability

The ideal candidate should demonstrate a strong combination of technical analytical and operational skills to support AI-enabled optimization resource planning and validation-related initiatives within Drug Product.A standout candidate would have experience or demonstrated capability