On-Site QA Specialist - 2nd Shift, Impactful Work
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Job summary
Amgen Easton site is seeking a Specialist Quality Assurance for the 2nd shift to provide critical QA support for raw material center operations. The role involves incoming material inspection, documentation review, GMP/GDP compliance, and collaboration with logistics service providers to ensure quality and regulatory readiness.
The candidate should have advanced degrees in Life Sciences with QA experience and strong communication skills for cross-functional teams.
Qualifications
- Doctorate or Master’s + QA experience as listed in qualifications.
- Experience with regulatory audits and inspections preferred.
- Knowledge of GMP, GDP, and import/export standards.
- Strong communication with cross-functional teams and diverse cultures.
Responsibilities
- Ensure operations align with GMP, GDP, GDP, and related Amgen requirements.
- Conduct sampling and inspection of incoming raw materials; assess documentation.
- Review documentation for receipt, storage, and distribution.
- Approve GMP processes and address deviations, CAPAs, and change controls.
- Perform QA assessments and provide operational oversight.
- Mentor staff and partner organizations; train teams.
- Oversee logistics providers and service levels; optimize performance.
- Provide QA guidance to cross-functional teams; ensure staff training.
Skills
Education
Tools
Job description
Amgen Easton site is seeking a Specialist Quality Assurance for the 2nd shift to provide critical QA support for raw material center operations. The role involves incoming material inspection, documentation review, GMP/GDP compliance, and collaboration with logistics service providers to ensure quality and regulatory readiness.
The candidate should have advanced degrees in Life Sciences with QA experience and strong communication skills for cross-functional teams.
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