QA Lab Compliance Specialist — cGMP & Data Integrity

Fagron Nederland BV; Wichita (KS); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

Restaurant d'entreprise

Indemnités de stage/alternance

Job summary

The Quality Assurance Associate at Fagron Nederland BV will support quality compliance by acting as the on-site owner of quality systems, data review, and disposition of laboratory testing at Fagron Analytical Services (FAS).

This role serves as liaison to Chemistry, Microbiology, and other functions to uphold cGMP compliance and data integrity, with authority to approve or reject procedures, results, investigations, and dispositions.

Qualifications

• Bachelor’s degree in chemistry, biology, microbiology, or a related scientific field is required.
• Minimum 2 years of quality assurance or quality-control experience in a cGMP laboratory.
• Knowledge of cGMP (21 CFR Parts 210 & 211), GDP, and 21 CFR Part 11.
• Ability to review data, investigations, and controlled documents independently.
• Strong attention to detail and compliance with procedures.
• Excellent communication with colleagues, auditors, and suppliers.

Responsibilities

• Maintain the Quality Management System, SOPs, document control, deviations, CAPA, and management reviews.
• Review and approve or reject laboratory results, worksheets, and COAs for Chemistry and Microbiology.
• Lead investigations (OOS/OOT, deviations) and close investigations with disposition.
• Initiate and track CAPA, assign owners, due dates, and verify effectiveness.
• Oversee change control for methods, equipment, and software, ensuring risk is evaluated.
• Review method validation, verification, transfer, and equipment qualification packages.
• Manage sample receipt, chain of custody, storage, retention, and disposal.
• Ensure data integrity for paper and electronic records (Empower, Chromeleon, LIMS).
• Administer training and competency program; verify analysts are trained.
• Support supplier qualification and quality agreements for critical labs and standards.
• Assist internal audits and regulatory inspections; prepare responses.
• Trend quality metrics and escalate unresolved issues to Quality Leader.
• Follow SOPs for handling of controlled substances and hazardous materials.

Skills

Attention to detail

Communication with auditors

Independent decision making

Data review

Quality systems experience

Education

Bachelor's degree in chemistry, biology, microbiology, or related scientific field

Tools

LIMS TEEXMA

Empower

Chromeleon

Job description

The Quality Assurance Associate at Fagron Nederland BV will support quality compliance by acting as the on-site owner of quality systems, data review, and disposition of laboratory testing at Fagron Analytical Services (FAS).

This role serves as liaison to Chemistry, Microbiology, and other functions to uphold cGMP compliance and data integrity, with authority to approve or reject procedures, results, investigations, and dispositions.