QA Lab Manager

Fagron Nederland BV; Wichita (KS); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

401(k) with company match

Health savings account (HSA)

Medical, vision, dental insurance

Paid time off

Job summary

Fagron Analytical Services seeks a Quality Assurance Manager to establish and lead the on-site Quality Unit, owning the quality systems, data review, and disposition of laboratory testing. This role operates independently of bench testing and reports to the Quality Leader, FSS North America.

You will manage CAPA, change control, document control, and supplier qualifications, ensuring compliance with 21 CFR Part 11 and GDP standards across Chemistry and Microbiology operations.

Qualifications

• Bachelor’s degree in chemistry, biology, microbiology, or related field, required.
• Minimum 5 years of quality assurance in cGMP pharma/analytical lab environment.
• Knowledge of cGMP (21 CFR Parts 210 & 211) and 21 CFR Part 11.
• Ability to review laboratory data, investigations, and documents and approve/reject independently.
• Strong attention to detail and commitment to compliance with procedures.
• Ability to communicate with auditors, colleagues, and suppliers clearly.

Responsibilities

• Establish and maintain the Quality Management System (QMS) including SOPs and change control.
• Review and disposition laboratory results, worksheets, and COAs for Chemistry and Microbiology.
• Own investigation program (OOS/OOT, deviations, invalid assays) and close investigations.
• Lead CAPA processes: root cause, ownership, due dates, effectiveness checks.
• Own document control: issue/revise/obsolete/ archive SOPs and reports.
• Oversee method validation/verification and equipment qualification packages.

Skills

Quality leadership

Regulatory knowledge

Attention to detail

Data review

Communication

Education

Bachelor’s degree in chemistry/biology/microbiology

Advanced degree preferred

Tools

TEEXMA LIMS

Empower

Chromeleon

Document-control tools

Job description

About The Job

The Quality Assurance Manager will establish and lead the on-site Quality Unit for Fagron Analytical Services. This position owns the quality systems, data review, and disposition of laboratory testing at FAS and is independent of laboratory operations under 21 CFR 211.22.

The Quality Assurance Manager has the authority to approve or reject procedures, methods, results, investigations, and dispositions. This position reports to the Quality Leader, FSS North America, serves as the primary liaison to Chemistry, Microbiology, Sample Administration, and other functional areas within FAS, and escalates unresolved quality issues to the Quality Leader. This seat does not run the controlled-substance vault and does not perform bench testing.

Key Responsibilities

• Establish and maintain the FAS Quality Management System. This includes but is not limited to the Quality Manual and Quality Policy, master SOP index, document control, change control, deviations, CAPA, training records, and management-review inputs.
• Own the review and disposition of laboratory results, worksheets, chromatograms, and certificates of analysis for Chemistry and Microbiology testing. This is the Quality Unit disposition authority for FAS release.
• Own the investigation program. This includes but is not limited to OOS and OOT investigations, invalid assays, aborted runs, deviations, and documentation errors. Close investigations and decide disposition.
• Own CAPA. Confirm root cause, assign owners and due dates, verify effectiveness, and trend recurrence.
• Own document control. Issue, revise, obsolete, and archive SOPs, protocols, reports, forms, and controlled logbooks. Ensure only the current approved version is in use in the laboratory.
• Own change control for methods, equipment, software, facilities, materials, and procedures. Evaluate risk and impact and verify implementation before the change is used for reportable testing.
• Own the approval of method validation, verification, transfer, and equipment qualification (IQ/OQ/PQ) packages before the method or instrument is used for GMP testing.
• Set the quality standard for sample management. This includes but is not limited to receipt, identification, chain of custody, storage, retention, and disposal, and review of controlled-substance inventories and destruction paperwork. This role does not own the vault.
• Own data integrity for paper and electronic records used by FAS, including Empower, Chromeleon, and LIMS (TEEXMA). Apply 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 they execute a method.
• Own supplier qualification and quality agreements for critical laboratory suppliers, reference standards, and contract laboratories.
• Own 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 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.

Basic Qualifications

• Bachelor’s degree in chemistry, biology, microbiology, or a related scientific field required. Advanced degree preferred.
• Minimum 5 years of quality assurance experience in a cGMP pharmaceutical, 503B, or analytical laboratory environment. Prior experience leading or establishing a Quality Unit preferred.
• 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 required.
• 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 by written communications 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.

What's on Offer?

• Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

Ready For The Challenge?

We’re proud to be an equal opportunity employer. Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.