QA Lab Manager

Fagron•Wichita, KS

1d•Onsite

About The Position

The Quality Assurance Manager will establish and lead the on-site Quality Unit for Fagron Analytical Services. The position owns quality systems, data review, and disposition of laboratory testing, and is independent of laboratory operations under 21 CFR 211.22. The role has authority to approve or reject procedures, methods, results, investigations, and dispositions. It reports to the Quality Leader, FSS North America, serves as the primary liaison to Chemistry, Microbiology, Sample Administration, and other FAS functional areas, and escalates unresolved quality issues to the Quality Leader. The role does not run the controlled-substance vault or perform bench testing. The position leads the Quality Management System and is responsible for laboratory-result disposition, investigations, CAPA, document and change control, method and equipment qualification approvals, sample-management standards, data integrity, training and competency, supplier qualification, audits and regulatory inspections, and quality metrics.

Requirements

Bachelor’s degree in chemistry, biology, microbiology, or a related scientific field.
At least 5 years of quality assurance 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.
Knowledge of 21 CFR 211.22 Quality Unit independence.
Ability to independently review and approve or reject laboratory data, investigations, and controlled documents.
Excellent attention to detail and commitment to consistency and compliance with established procedures.
Ability to communicate clearly, straightforwardly, and professionally with colleagues, auditors, and suppliers in person, by phone, and in writing.
Ability to meet requirements for handling controlled substances and hazardous materials, as applicable.
Familiarity with or willingness to learn LIMS (TEEXMA), chromatographic data systems (Empower and/or Chromeleon), and site document-control tools.

Nice To Haves

Advanced degree.
Prior experience leading or establishing a Quality Unit.

Responsibilities

Establish and maintain the FAS Quality Management System, including the Quality Manual and Policy, master SOP index, document control, change control, deviations, CAPA, training records, and management-review inputs.
Review and disposition laboratory results, worksheets, chromatograms, and certificates of analysis for Chemistry and Microbiology testing; serve as the Quality Unit disposition authority for FAS release.
Own investigations of OOS and OOT results, invalid assays, aborted runs, deviations, and documentation errors; close investigations and determine disposition.
Own CAPA by confirming root causes, assigning owners and due dates, verifying effectiveness, and tracking recurrence.
Issue, revise, obsolete, and archive controlled documents and ensure current approved versions are used in the laboratory.
Own change control for methods, equipment, software, facilities, materials, and procedures; evaluate risks and impacts and verify implementation before reportable testing.
Approve method validation, verification, transfer, and equipment qualification (IQ/OQ/PQ) packages before use for GMP testing.
Set quality standards for sample receipt, identification, chain of custody, storage, retention, and disposal; review controlled-substance inventories and destruction paperwork.
Own data integrity for FAS paper and electronic records, including records in Empower, Chromeleon, and LIMS (TEEXMA), applying GDP, ALCOA+, and 21 CFR Part 11 requirements.
Own the training and competency program, maintain training records, and confirm analysts are trained and authorized before executing methods.
Qualify suppliers and manage quality agreements for critical laboratory suppliers, reference standards, and contract laboratories.
Conduct internal audits and host regulatory inspections; retrieve records, host auditors on quality-system topics, and own Quality Unit responses and commitments.
Establish and own quality metrics for 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.