Quality Auditor II

Piper Companies is currently looking for an experienced Quality Assurance Auditor in Baltimore, 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
•  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 $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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