Night QA Specialist II - Biopharma Quality Systems

AstraZeneca; Frederick (MD); On-site; USD 80,000 - 120,000; Full time

Job summary

Join AstraZeneca as a Quality Assurance Specialist II at the Frederick Manufacturing Center. This role provides QA oversight for manufacturing and operations in a biopharmaceutical setting, including batch record review, area release, and audits.

You will work with Manufacturing, QC, Validation, Engineering, and Quality Systems to ensure compliance with procedures and regulations. Shift: Nights, 6pm–6:30am (2–2–3 schedule).

Qualifications

• Bachelor’s degree.
• Minimum of three years of experience in a biopharmaceutical or pharmaceutical environment.
• Minimum of one year of experience in Quality Assurance, Quality Control, Validation, or a related quality function.
• Experience reviewing paper‑based and electronic manufacturing documentation in a regulated environment.
• Experience working with quality systems, manufacturing records, deviations, observations, and compliance processes.
• Familiarity with electronic manufacturing and quality systems, such as PAS‑X, DeltaV, PCS/BMS, GQCLIMS, LAP MODA, and SAP, is preferred or required according to site needs.

Responsibilities

• Batch Review and Release: review and release for paper and electronic batch records with compliance.
• Area Release Activities: support product changeover and hold processes.
• Area Audits: conduct quarterly audits and document findings.
• Lot Genealogy Reports: prepare and review reports for traceability.
• Quality Systems Support: backup support for Quality Systems.
• Deviation Assessment: assess events to determine need for deviation initiation.
• Floor Observations: review and close floor observations.
• Autoclave Review: verify autoclave cycles compliance.
• Electronic Logbook Review: review PAS‑X and DeltaV logs.
• PCS/BMS Alarm Review: evaluate alarms for quality impact.
• Quality and Manufacturing Systems: use site systems like GQCLIMS, LAP MODA, SAP.
• Continuous Improvement: participate in Lean and improvement projects.
• Additional Responsibilities: support other quality projects as assigned.

Skills

Quality assurance

Documentation review

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree

Tools

PAS-X

DeltaV

PCS/BMS

GQCLIMS

LAP MODA

SAP

Job description

Join AstraZeneca as a Quality Assurance Specialist II at the Frederick Manufacturing Center. This role provides QA oversight for manufacturing and operations in a biopharmaceutical setting, including batch record review, area release, and audits.

You will work with Manufacturing, QC, Validation, Engineering, and Quality Systems to ensure compliance with procedures and regulations. Shift: Nights, 6pm–6:30am (2–2–3 schedule).