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Quality Assurance Specialist
2 months ago
Location: Bothell, WA
Duration: Months contract on W
% onsite
Work Schedule: Sunday-Wednesday, PM - :AM PST
Key Competencies:
Experience in Documentation Review Degree in a Scientific Field Familiarity with GMP Environments
Candidates with a recent degree in Biology or a related field seeking GMP exposure are encouraged to apply.
Responsibilities:
- Ensure quality presence on the shop floor; manage in-process materials and finished products; investigate and rectify GDP discrepancies.
- Conduct batch record evaluations to guarantee compliance with relevant regulations and standards.
- Assist in the preparation for regulatory and customer audits.
- Review and approve manufacturing formulation batch production records to support product release in line with specifications and SOPs.
- Inspect and authorize intermediates or packaged drug products based on specifications.
- Monitor various processing stages alongside the necessary documentation to ensure compliance with specifications.
- Draft and review specifications and SOPs.
- Track and analyze batch record errors, providing Quality Assurance management with quality indicator data.
- Offer guidance to junior staff as needed.
- Provide comprehensive support during daily inspections of GMP areas.
Qualifications:
Degree in Biology, Chemistry, or a related field is preferred. A minimum of 3 years of relevant experience in a regulated environment, with at least 2 years focused on product quality. Understanding of biotech product manufacturing processes. Familiarity with US and EU cGMP regulations and guidelines. Knowledge of Oracle, BMRAM, MES, and Veeva Infinity is advantageous.
