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QA Engineer

  1. East Coast
North Carolina
  1. Contract
Competitive
  1. Compliance / Quality Assurance
01-08-2023
31244

This vacancy has now expired

QA Engineer – Life Sciences – 12 Month Contract – North Carolina

Our client, a global Pharmaceutical manufacturing organization are looking for a talented QA Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

QA Engineer Responsibilities:
  • Perform an SME role within the QA team for the development of documents, processes, and procedures for the DSM program
  • Assess the impact of system and process modifications and maintain oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation
  • Provide oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
  • Generate, review, and approve QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
  • Generate, review, and approve QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
  • Ensure that project and operational quality objectives are met within desired timelines.
  • Actively seek opportunities to collaborate and align with other sites to streamline processes and maximize efficiency
About you:
  • BS in Life Sciences or Engineering
  • 8 + years of experience in GMP quality assurance and/or similar role
  • High level of familiarity/understanding of validation of production equipment
  • Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11
  • Understanding of one or more of the following processes is preferred:
    • Cell culture or fermentation
    • Large-scale recover processes
    • Formulation/fill
    • Finished goods and manufacturing
Are you a good fit for this QA Engineer position? Get in touch with us today.

The candidate must have the rights to work in the location stated in the job advert.

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