QA Specialist

Piper Health and Sciences is seeking a motivated QA Specialist to initiate, track and close quality records such as deviations, CAPAs, change controls, and OOS records for a well-established biotechnology company in the Baltimore, MD area.

Responsibilities of the QA Specialist:

• Initiate and revise SOPs (standard operating procedures)
• Review manufacturing batch records to ensure compliance with established regulations and procedures
• Initiate, monitor and close quality records including deviations, change controls, OOS, CAPAs and other records
• Review and approve cGMP documentation including cGMP logbooks
• Participate in internal and external vendor/client audits
• Perform on-the-floor QA including observing critical processes, reviewing real time batch documentation, room release, logbooks, and resolving any issues

 Qualifications of the QA Specialist:

• 2+ years of QA (quality assurance) experience working in a pharmaceutical or biotechnology
• Experience with initiating and tracking quality records such as deviations, OOS (out of specification), change controls and CAPAs, etc.
• Bachelor’s degree in science related field (preferred, not required)

 Compensation for the QA Specialist:

• Salary: Between $60,000 - $80,000 **based on years of relevant experience**
• Benefits: Full Medical, Dental, Vision Insurance & 401k Contributions

Keywords:

Document control, document management, document specialist, document control specialist, document control coordinator, QA specialist, Quality assurance, EDMS, electronic data management system, Veeva, Master Control, MasterControl, FDA, biotech, pharma, issuing documents, batch records, batch disposition, document management system, logbooks, controlled documents, document archival, GMP, cGMP, current good manufacturing practice, good manufacturing practice, GxP, trackwise, QMS, quality management system, quality compliance, quality systems fundamentals, Quality assurance, QA, CAPA, deviations, investigation, on the floor, room release, critical processes, manufacturing

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