ZP Group

Quality Assurance Auditor (Biotech)

Elkridge, MD, US

Onsite
Full-time
$27–$37/hour
4 days ago
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Summary

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: QA auditor, quality assurance auditor, quality assurance, quality assurance specialist, quality assurance technician, QA technician, QA specialist, QA on the floor, manufacturing, manufacturing associate, mastercontrol, quality management system, QMS, cGMP, current good manufacturing practice, GMP, good manufacturing practice, ISO, cleanrooms, critical processes, supplier change notifications, cGMP logbooks, logbooks, deviations, change controls, CAPA, Out of Specification, OOS, room release, raw materials, batch records, real time batch, visual inspection, FDA, regulatory agency inspection, quality compliance, product complaints, supplier complaints, vendor audits, supplier audit, audit, SOP, standard operating procedure #LI-BN1 #LI-ONSITE

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