Quality Auditor II Job at Piper Companies, Rockville, MD

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  • Piper Companies
  • Rockville, MD

Job Description

Piper Companies is currently looking for an experienced Quality Assurance Auditor in Rockville, MD in a hybrid role. Responsibilities for the Quality Assurance Auditor include:
  • Prepare, execute and follow-up of internal and external vendors and supplier audits
  • Initiate new SOPs and/or revise existing SOPs as needed
  • Initiation, tracking and closure of quality records like Deviations, Change Controls, CAPAs and Out of Specification (OOS) records
  • Conduct thorough technical reviews of manufacturing batch records to ensure compliance with established procedures, regulations, and quality standards
  • Performs QA on the Floor activities, including room release, observing critical processes, reviewing batch documentation in real time
Qualifications for the Quality Assurance Auditor include:
  • 2+ years' of relevant experience in pharmaceutical, biotechnology or biopharmaceutical industry in a GLP environment
  • 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 for the Quality Assurance Auditor include: • Salary Range is $70,000 - $80,000 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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