QA Lab Associate

Fagron•Wichita, KS

1d•Onsite

About The Position

The Quality Assurance Associate supports the quality compliance profile at Fagron Analytical Services and serves as the primary on-site resource for quality systems, data review, and disposition of laboratory testing. The role liaises with Chemistry, Microbiology, and other functional areas to promote awareness and cGMP compliance. It is independent of laboratory operations and has authority to approve or reject procedures, methods, results, investigations, and dispositions. The associate maintains the Quality Management System; reviews laboratory data and testing documentation; leads investigations and CAPA; controls documents, records, and changes; and reviews validation, verification, transfer, and equipment qualification packages. The role also oversees sample-management quality, data integrity, training and competency, supplier qualification, audits and inspections, and quality metrics. Unresolved quality issues are escalated to the Quality Leader, FSS North America.

Requirements

Bachelor’s degree in chemistry, biology, microbiology, or a related scientific field; equivalent cGMP quality experience may be considered.
At least 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 independently approve or reject them.
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.
Must be able to meet all applicable requirements for handling controlled substances and hazardous material.

Nice To Haves

Familiarity with, and/or willingness to learn, LIMS (TEEXMA), chromatographic data systems (Empower and/or Chromeleon), and site document-control tools.

Responsibilities

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 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, including confirming root cause, assigning owners and due dates, verifying effectiveness, and trending recurrence.
Issue, revise, obsolete, and archive SOPs, protocols, reports, forms, and controlled logbooks, and ensure only current approved versions are 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 methods or instruments are used for GMP testing.
Oversee sample management quality, including receipt, identification, chain of custody, storage, retention, and disposal; review controlled-substance inventories and destruction paperwork.
Ensure data integrity for paper and electronic records, including records in Empower, Chromeleon, and LIMS (TEEXMA), applying 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 methods.
Support supplier qualification and quality agreements for critical laboratory suppliers, reference standards, and contract laboratories.
Support internal audits and regulatory inspections by retrieving records, hosting auditors on quality-system topics, and owning 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 for compliant handling of laboratory records, hormone products, and controlled-substance testing documentation.