Biopharma Quality Assurance Specialist II — Nights
AstraZeneca GmbH
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Benefits offered by this job
Job summary
AstraZeneca Frederick Manufacturing Center is seeking a Quality Assurance Specialist II to provide QA oversight for manufacturing activities. You will review batch records (paper and electronic), conduct area releases, and support quality systems, deviations, and audits in a cross-functional team.
Nights shift available, with lean improvement involvement and comprehensive benefits. The role requires a bachelor’s in a science/engineering field and 3+ years in biopharma, with knowledge of PAS-X,
Qualifications
- Requires bachelor’s degree in biology, engineering, or a related field.
- Minimum of three years in biopharma/pharma; at least one year in QA, QC, Validation, or related function.
- Experience reviewing paper and electronic manufacturing documentation in a regulated environment.
Responsibilities
- Batch review and release for paper-based and electronic batch records.
- Support area release activities and quality holds as needed.
- Conduct quarterly area audits and document findings.
- Prepare and review lot genealogy reports for traceability.
- Provide backup support to Quality Systems and lean improvement projects.
- Assess quality events to determine if deviations are needed.
- Review autoclave runs and electronic logbooks for compliance.
- Evaluate alarms and ensure product quality and equipment performance.
Skills
Education
Tools
Job description
AstraZeneca Frederick Manufacturing Center is seeking a Quality Assurance Specialist II to provide QA oversight for manufacturing activities. You will review batch records (paper and electronic), conduct area releases, and support quality systems, deviations, and audits in a cross-functional team.
Nights shift available, with lean improvement involvement and comprehensive benefits. The role requires a bachelor’s in a science/engineering field and 3+ years in biopharma, with knowledge of PAS-X,
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