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
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