QA Lab Compliance Lead — cGMP & Data Integrity

Fagron; Wichita (KS); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical insurance

Vision and dental plans

Health Savings Account (HSA)

Paid holidays

Job summary

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.

Responsibilities

• 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.

Skills

Attention to detail

Communication skills

Data review

LIMS TEEXMA familiarity

Education

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

Tools

Empower

Chromeleon

TEEXMA (LIMS)

Job description

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,