What are the responsibilities and job description for the QA Auditor position at Zachary Piper LLC?
Piper Health & Sciences is seeking a QA Auditor to support cGMP quality and manufacturing operations for a mid-size biopharmaceutical company in the Columbia, MD area. This role ensures accurate and compliant release of drug products following cGMP guidelines.
Responsibilities for the QA Auditor include:
- Review, revise, and approve of cGMP documents such as batch records, logbooks, and SOPs.
- Initiate and monitor quality records including Deviations, Change Controls, CAPAs, and Out of Specification (OOS) results.
- Review and approve the release of raw materials.
- Perform QA on the floor activities such as quality observation, real-time batch record review, cleaning documentation, and addressing any issues with manufacturing.
- Participate in internal and local external audits as needed.
- Collaborate across quality and manufacturing departments to ensure training and quality system compliance.
- Assist with tracking and reporting of quality metrics/KPIs.
Qualifications for the QA Auditor include:
- 3 years of quality assurance experience within the pharmaceutical and/or biotechnology industry.
- Proven experience operating under current Good Manufacturing Practices (cGMP).
- Experience reviewing batch records and conducting internal audits is highly preferred.
- Knowledge of MasterControl is preferred, but not required.
Compensation for the QA Auditor includes:
- Salary Range: approximately $70,000 - $85,000 annually, commensurate with experience
- Comprehensive Benefits: Medical, Dental, Vision, 401k, PTO, Paid Holidays, STD, LTD, Paid Sick leave (as required by law)
This role is open for applications on 4/2/2025. Applications will be accepted at least 30 days from the posting date.
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Job Id:
140123
Job Category:
Life Sciences
Job Location:
Columbia, MD
Security Clearance:
No Clearance
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Cassandra Parisi
Salary : $70,000 - $85,000
