QA Lab Lead - GMP Compliance & Systems

Fagron; Wichita (KS); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

401(k) plan with company matching

Medical, vision and dental

Health Savings Account (HSA)

Paid time off

Job summary

Fagron US seeks a Quality Assurance Manager to lead the on-site Quality Unit for Fagron Analytical Services, owning quality systems, data review, and disposition of laboratory testing at FAS. Independent of bench operations, this role reports to the Quality Leader and interfaces with Chemistry, Microbiology, and Sample Administration.

The role emphasizes CAPA, document control, training, supplier quality, and audits, with a strong focus on data integrity and regulatory compliance.

Qualifications

• Bachelor’s degree in science required.
• Minimum 5 years of quality assurance in a cGMP environment.
• Experience leading or establishing a Quality Unit preferred.
• Knowledge of 21 CFR Part 11 and GDP required.

Responsibilities

• Establish and maintain the FAS Quality Management System.
• Review and disposition of laboratory results and COAs.
• Oversee investigation program including OOS/OOT investigations.
• Own CAPA process, root-cause analysis, and trend reviews.
• Manage document control, change control, and SOP lifecycle.
• Approve method validation, verification, transfer, IQ/OQ/PQ packages.
• Set quality standards for sample management, receipt, custody, and disposal.
• Ensure data integrity for paper and electronic records (LIMS/EDR).
• Oversee training and competency program for analysts.
• Manage supplier qualification and quality agreements for critical suppliers.
• Lead internal audits and respond to regulatory inspections.
• Establish and monitor quality metrics and escalate unresolved issues.

Skills

Attention to detail

Quality management

Leadership

Education

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

Advanced degree preferred

Tools

LIMS TEEXMA

Empower

Chromeleon

Job description

Fagron US seeks a Quality Assurance Manager to lead the on-site Quality Unit for Fagron Analytical Services, owning quality systems, data review, and disposition of laboratory testing at FAS. Independent of bench operations, this role reports to the Quality Leader and interfaces with Chemistry, Microbiology, and Sample Administration.

The role emphasizes CAPA, document control, training, supplier quality, and audits, with a strong focus on data integrity and regulatory compliance.