QA Lab Associate

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

Avantages offerts par ce poste

401(k) plan with company match

Medical insurance

Vision and dental plans

Health Savings Account (HSA)

Paid holidays

Résumé du poste

Fagron US seeks a Quality Assurance Associate to serve as the on-site quality systems lead, overseeing data review and disposition of laboratory testing at Fagron Analytical Services. You will liaise with Chemistry, Microbiology, and other areas to sustain cGMP compliance and the culture of awareness.

This role has authority to approve or reject procedures, methods, results, investigations, and dispositions, and requires ensuring data integrity per 21 CFR 11, ALCOA+, and GDP in Empower,

Qualifications

• Bachelor's degree in chemistry, biology, microbiology, or a related scientific field is required or equivalent cGMP experience.
• Minimum 2 years QA or QA/QC in a cGMP pharma/analytical lab.
• Knowledge of cGMP (21 CFR Parts 210/211), GDP, and 21 CFR Part 11 electronic records.

Responsabilités

• Maintain the Quality Management System (QMS) including SOPs, change control, deviations, CAPA, and document control.
• Review/approve/reject laboratory results, worksheets, chromatograms, and COAs for Chemistry and Microbiology testing.
• Lead investigations (OOS/OOT, deviations, invalid assays), close investigations and determine disposition.
• Initiate, own, and track CAPA with root cause analysis and effectiveness checks.
• Control documents and records; ensure current approved versions are used in the lab.
• Administer change control for methods, equipment, software, facilities, materials, and procedures.
• Review/approve method validation, verification, transfer, andIQ/OQ/PQ packages.
• Oversee sample management, chain of custody, storage, retention, and disposal.

Connaissances

Attention to detail

Communication skills

Data review

LIMS TEEXMA familiarity

Formation

Bachelor's degree in chemistry/biology/microbiology or related field

Outils

Empower

Chromeleon

TEEXMA (LIMS)

Description du poste

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. 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.

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 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.