GMP QA Lab Specialist & Quality Compliance

Fagron Tech; Wichita (KS); Sur place; USD 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

401(k) match

Medical, Vision and Dental

HSA and holidays

Résumé du poste

Fagron Analytical Services is seeking a Quality Assurance Associate to serve as the on-site quality systems lead, overseeing data review and disposition of laboratory testing. This role acts as a liaison across Chemistry, Microbiology and other functions to uphold cGMP compliance in a non-operational capacity.

Responsibilities include maintaining the Quality Management System, approving or rejecting lab results, leading investigations (OOS/OOT, deviations), driving CAPA, and ensuring data

Qualifications

• Bachelor’s degree in chemistry, biology, microbiology, or related science field.
• 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 by written communications in a clear, straightforward, and professional manner.

Responsabilités

• 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.
• Review and approve or reject laboratory results, worksheets, chromatograms, and certificates of analysis for Chemistry and Microbiology testing.
• Lead laboratory investigations. This includes but is not limited to 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 in the laboratory.
• Administer 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.
• Review and approve method validation, verification, transfer, and equipment qualification (IQ/OQ/PQ) packages before the method or instrument is used for GMP testing.
• Oversee sample management quality. 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.
• Ensure 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.
• Administer the training and competency program. Maintain training records and confirm analysts are trained and authorized before they execute 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.

Connaissances

Attention to detail

Independent reviewer

Communication skills

Quality mindset

Formation

Bachelor’s degree in chemistry, biology, microbiology, or related field

Outils

LIMS TEEXMA

Empower

Chromeleon

Description du poste

Fagron Analytical Services is seeking a Quality Assurance Associate to serve as the on-site quality systems lead, overseeing data review and disposition of laboratory testing. This role acts as a liaison across Chemistry, Microbiology and other functions to uphold cGMP compliance in a non-operational capacity.

Responsibilities include maintaining the Quality Management System, approving or rejecting lab results, leading investigations (OOS/OOT, deviations), driving CAPA, and ensuring data