Quality Assurance Auditor (Biotech)

Piper Health & Sciences is seeking a detail-oriented and organized Quality Assurance Auditor to join a well-established biotechnology company in the Elkridge, MD area. 

Responsibilities of the QA Auditor:

·       Review, process, and approve executed GMP documentation

·       Responsible for the initiation, tracking and, closure of quality records such as change controls, CAPAs, deviations, and OOS records

·       Perform QA on-the-floor activities including reviewing real-time batch record documentation, room release, observing critical processes, visual inspection, and handling any issues throughout the manufacturing process

·       Approve and release of raw materials

·       Assist with tracking and reporting of quality activities and approve cGMP logbooks

Qualifications of the QA Auditor:

·       2+ years of experience working in a GMP environment (Biotechnology or Pharmaceutical organization) in quality assurance (QA) position

·       Experience working with change controls, CAPAs, deviations and, out-of-specification (OOS) records is required

·       QA on-the-floor experience preferred

·       Experience gowning to perform QA functions in a manufacturing environment in ISO 5-8 cleanrooms

·       Strong GMP knowledge

·       Bachelor’s degree in science-related field

Benefits of the QA Auditor:

·       Salary: Between $27.00 - $37.00/hourly based on years of experience

·       Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave as required by law

This job opens for applications on 05/02/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords:

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