cGxPServe

Responsibilities: Support Victaulics New Product Development (NPD) teams from ideation to launch. Responsible for ensuring Quality related elements of the NPD process such as Past Performance Analysis FMEAs and first part approvals. Evaluate customer complaints to determine prelimin More...

Roles & Responsibilities: Provide critical support on LEANPDdriven new product development projects. Drive continuous improvement in existing manufacturing technologies and methods. Identify and implement new technologies to improve process control and tolerance management. Serve as More...

Responsibilities: The scope of work for this role is to support the current senior operations quality engineer on a product transfer project from another site to this facility. Specifically Im looking for a person who can. Review risk management files (pFMEA). Review process validati More...

Responsibilities: Ensure IT processes and procedures meet Quality System requirements. Participate and support the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives. Support the development review and approval of Quality Assurance Agreeme More...

Roles & Responsibilities: Bachelors or Masters in Life Sciences Biomedical Engineering Computer Science or related discipline. 8 years of QA experience in medical or veterinary diagnostic devices (chemistry hematology pathology). Strong understanding of OEM device interfaces communic More...

Responsibilities: You are a problem solver. Complex projects or unexpected challenges are just opportunities to bring your considerable abilities to use. Whether working independently or with a trusted team you are always ready to take on a project and work hard to find solutions. Yo More...

Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Lead and support small to medium sized projects with global crossfunctional teams in the implementation o More...

Responsibilities: Looking for a senior operations quality engineer for six months from the beginning of June. The scope of work for this role is to support the current senior operations quality engineer on a product transfer project from another site to this facility. Specifically Im More...

Roles & Responsibilities: Bachelors Degree in an Engineering discipline from an accredited institution required. Complaint product analysis and testing per procedures and requirements. Root cause analysis and supports conclusions with objective evidence and sound rationale. Complaint More...

Job Description: This Computer Systems Quality Assurance role will be responsible for supporting the expansion of clients ERP systems and associated applications to new and existing manufacturing sites. The role will deliver quality oversight to ensure assigned systems are developed a More...

Responsibilities: Validate and create SDTM ADaM and Tables Figures and Listings (TFLs) including associated documentation like using SAS. Write or review data specifications for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM). Handson statistical programming to sup More...

Roles & Responsibilities: 10 years experience in Computer System Validation ERP/WMS R&D systems. A senior consultant with expert knowledge of GxP and Computer System Validation. Expertise in authoring and reviewing all CSV validation deliverables. Proficient in Compliance Plan User S More...

Roles & Responsibilities: Solution Architecture and Design: Lead the design and development of Lab Vantage LIMS solutions tailored to business and laboratory needs. Develop system workflows configurations and integrations with other enterprise systems (e.g. S4 Hana ERP MES ELN SDMS). More...

Roles & Responsibilities: Sustaining Manufacturing Line Support Day to Day Line Support (Laser welding/UV Bonding/Assembly). Root cause analysis / NCMRs and Deviations. Experienced in drafting executing process validations with knowledge on riskbased sampling plan. Experience wo More...

Roles & Responsibilities: Packaging Operator I is responsible for performing on a daily basis all direct and indirect activities assigned to them in the packaging area with the ability to follow both written and verbal work instructions. The tasks required of this position include bu More...

Responsibilities: Support the Team Lead in clutch housing designs. Perform concept modeling and CREO stress analysis. Coordinate detailing with external teams. Review PPAPs (Production Part Approval Process). Conduct design assessments and review deviations on nonconforming materials More...

Responsibilities: Prepare review and submit regulatory documents to FDA. Manage and oversee the regulatory submission process ensuring timely and successful clearances/approvals. Ensure that all products comply with applicable regulatory requirements including FDA regulations and ISO More...

Job Description: Inventory Cycle Counter is responsible for maintaining a high level of inventory accuracy and integrity. Perform cycle counts recounts item stock and other duties within the department. Responsibilities: Cycle count bulk and pick aisles to assist with KDG objectives More...

Responsibilities: Support the endtoend clinical data management process for assigned studies from protocol review to database lock. Collaborate with crossfunctional teams including clinical operations biostatistics and medical writing to define data collection and reporting needs. Re More...

Responsibilities: Validation Plan Development: Creating comprehensive validation plans that outline the steps for verifying equipment performance. Risk Assessment: Identifying and assessing potential risks associated with using the equipment. IOQ (Installation Qualification) OQ (Oper More...