QA Generalist

Piper Health Sciences is seeking a QA Generalist II to join a clinical-stage biotech company in Elkridge, MD. The QA Generalist II performs technical functions in the Quality Assurance group.

Responsibilities of the QA Generalist II include:

• Prepare, execute, and follow up on internal vendor/supplier audits
• Maintain quality records like deviations, change controls, CAPAs, and Out of Specification (OOS) records
• Conduct technical reviews of manufacturing batch records to ensure compliance
• Perform on-the-floor QA activities, including critical processes, room release, batch documentation review, logbooks, etc.

Qualifications for the QA Generalist II include:

• 2+ years of QA experience in a GMP environment
• Previous experience with reviewing batch records and on-the-floor QA activities
• Experience using electronic document control systems
• Associate degree or Bachelor's degree

 Compensation for the QA Generalist II includes:

• Salary Range: $70,000 - 85,000 **depending on experience**
• Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401k

Keywords: QA, quality assurance, biotechnology, pharmaceutical, GMP, SOP, eDMS, electronic document control system, document approval, editing, Mastercontrol, master control, batch records, Veeva, Compliance Wire, Agile, QMS Systems, document filing, batch review, batch release, electronic document management system, Quality Systems fundamentals, quality systems, batch disposition, quality compliance, biotech, pharma, pharmaceuticals, document specialist, document control specialist, trackwise, 21 CFR, EU regulations, Quality control, training records, document updating, document editing, document formatting, biopharmaceutical, OOS, out of specification, CAPAs, change controls, deviations, on the floor, room release, logbooks, QA generalist, Quality assurance auditor, QA auditor

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