QA Manager
Elkridge, MD
Job Id:
130216
Job Category:
Job Location:
Elkridge, MD
Security Clearance:
None
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Emily Mills
Piper Companies is currently looking for a QA Manager in a 100% on-site role.
Responsibilities for the QA Manager include:
- Prepare, execute and follow-up of internal and external vendors and supplier audits
- Initiate new SOPs and/or revise existing SOPs as needed
- Initiation, tracking and closure of quality records like Deviations, Change Controls, CAPAs and Out of Specification (OOS) records
- Conduct thorough technical reviews of manufacturing batch records to ensure compliance with established procedures, regulations, and quality standards
- Manage QA team
- Performs QA on the Floor activities, including room release, observing critical processes, reviewing batch documentation in real time
Qualifications for the QA Manager include:
- 5+ years’ of relevant experience in pharmaceutical, biotechnology or biopharmaceutical industry
- Experience with Batch record review, out of specification results, and CAPA investigations
- Knowledge of electronic documentation Quality Management Systems a plus
- Experience managing team
- Bachelor’s or Master's degree in life sciences, preferably biology or chemistry
Compensation for the QA Auditor II includes:
- Salary Range: $90,000-$110,000 based on experience
- Comprehensive benefit package: medical/dental/vision/prescription coverage, 401k
- Perks: Employee Wellness resources, PTO
Keywords: quality auditor, batch records, external vendor, internal vendor, supplier audits, SOPs, manufacturing, compliance, CAPA, specification results, quality, pharmaceutical, biotechnology, biopharmaceutical, GMP, good manufacturing practices, quality assurance auditor
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