Location: Elkridge,MD, USA
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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