Quality Assurance Specialist
4 weeks ago
Piper Companies is seeking an experienced Quality Assurance Auditor to join their team in Baltimore, MD. This hybrid role will involve conducting internal and external vendor audits, initiating new SOPs, and tracking quality records.
Key Responsibilities:
- Prepare and execute audits of internal and external vendors and suppliers
- Develop and implement new SOPs as needed
- Manage quality records, including deviations, change controls, CAPAs, and OOS records
- Conduct technical reviews of manufacturing batch records to ensure compliance with established procedures and regulations
- Perform QA on the floor activities, including room release and reviewing batch documentation in real-time
Requirements:
- 2+ years of relevant experience in the 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
- Bachelor's degree in life sciences, preferably biology or chemistry
Compensation:
Salary range: $75,000 - $90,000 based on experience
Keywords:
Quality Control Analyst, Oncology, Flow Cytometry, Elisa, PCR, Cell-Based Assays, Batch Release, Sample Testing, Maintenance, Calibration, Tech Transfer, Authoring Protocols, Assays, Environmental Monitoring
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