QA Lab Associate

About the Job

The Quality Assurance Associate will support the quality compliance profile by acting as the primary on-site person responsible for quality systems, data review, and disposition of laboratory testing at Fagron Analytical Services. Additionally, the Quality Assurance Associate will serve as liaison to Chemistry, Microbiology, and other functional areas within the FAS organization to support an overall culture of awareness and cGMP compliance. This position is independent of laboratory operations and has the authority to approve or reject procedures, methods, results, investigations, and dispositions.

Key Responsibilities

• Maintain the FAS Quality Management System, including the Quality Manual and Quality Policy, master SOP index, document control, change control, deviations, CAPA, training records, and management-review inputs.
• Review and approve or reject laboratory results, worksheets, chromatograms, and certificates of analysis for Chemistry and Microbiology testing.
• Lead laboratory investigations, including OOS and OOT investigations, invalid assays, aborted runs, deviations, and documentation errors; close investigations and decide disposition.
• Initiate, own, and track CAPA; confirm root cause, assign owners and due dates, verify effectiveness, and trend recurrence.
• Control documents and records; issue, revise, obsolete, and archive SOPs, protocols, reports, forms, and controlled logbooks; ensure only the current approved version is in use.
• Administer change control for methods, equipment, software, facilities, materials, and procedures; evaluate risk and impact and verify implementation before use for reportable testing.
• Review and approve method validation, verification, transfer, and equipment qualification (IQ/OQ/PQ) packages before use for GMP testing.
• Oversee sample management quality, including receipt, identification, chain of custody, storage, retention, disposal, and review of controlled-substance inventories and destruction paperwork.
• Ensure data integrity for paper and electronic records, including Empower, Chromeleon, and LIMS (TEEXMA); apply GDP, ALCOA+, and 21 CFR Part 11 requirements.
• Administer the training and competency program; maintain training records and confirm analysts are trained and authorized before executing a method.
• Support supplier qualification and quality agreements for critical laboratory suppliers, reference standards, and contract laboratories.
• Support internal audits and regulatory inspections; retrieve records, host auditors on quality-system topics, and own Quality Unit responses and commitments.
• Trend quality metrics including deviations, OOS results, invalid assays, training gaps, overdue document reviews, CAPA aging, and audit findings; escalate unresolved quality issues to the Quality Leader, FSS North America.
• Follow standard operating procedures to ensure compliant handling of laboratory records, hormone products, and controlled-substance testing documentation.

Basic Qualifications

• Bachelor’s degree in chemistry, biology, microbiology, or a related scientific field required; equivalent cGMP quality experience may be considered.
• Minimum 2 years of quality assurance or quality-control experience in a cGMP pharmaceutical, 503B, or analytical laboratory environment.
• Working knowledge of cGMP (21 CFR Parts 210 and 211), GDP, and electronic-record requirements under 21 CFR Part 11.
• Ability to review laboratory data, investigations, and controlled documents and to approve or reject them independently.
• Excellent attention to detail and commitment to maintaining consistency and compliance with established procedures.
• Ability to communicate with colleagues, auditors, and suppliers in person, on the phone, and in writing in a clear, straightforward, and professional manner.
• Must be able to meet all requirements for handling of controlled substances and hazardous material, as applicable.
• Familiarity with and/or willingness to learn LIMS (TEEXMA), chromatographic data systems (Empower and/or Chromeleon), and site document-control tools.