Quality Auditor II

Piper Companies is currently looking for a QA Auditor II in Elkridge, MD in a 100% on-site role. 

Responsibilities for the QA Auditor II 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 QA Auditor II 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 QA Auditor II includes:

• Salary Range: $70,000-$80,000 based on experience
• Comprehensive benefit package: medical/dental/vision/prescription coverage, 401k
• Perks: Employee Wellness resources, PTO

Keywords: quality auditor, batch records, external vendor, internal vendor, supplier audits, SOPs, manufacturing, compliance, CAPA, specification results, quality, pharmaceutical, biotechnology, biopharmaceutical, GMP, good manufacturing practices, quality assurance auditor

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