QA Lab Lead: cGMP Compliance & Data Integrity

Fagron Tech; Wichita (KS); Presencial; USD 110.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) plan with company match

Medical, vision and dental

Health savings account (HSA)

Holiday/PTO

Descripción de la vacante

Fagron is seeking a Quality Assurance Manager to lead the on-site Quality Unit for FAS. You will own the quality systems, data review, and disposition of laboratory testing, operating independently of bench work and reporting to the Quality Leader, FSS North America.

The role requires escalation of unresolved issues, CAPA ownership, and governance of document control and method validation packages. On-site position in a regulated lab environment.

Formación

• Bachelor’s degree in chemistry, biology, microbiology or related scientific field.
• Minimum 5 years of quality assurance in a cGMP pharma, 503B or analytical lab.
• Knowledge of 21 CFR 11, GDP, and QA independence requirements.
• Ability to review data and approve/reject documents independently.

Responsabilidades

• Establish and maintain the Quality Management System (QMS) for FAS.
• Review and disposition of laboratory results, certificates of analysis.
• Own investigations including OOS/OOT, deviations, and documentation errors.
• Own CAPA processes, root-cause analysis, and tracking corrective actions.
• Oversee document control, change control, and method validation approvals.

Conocimientos

Quality Assurance

cGMP

Regulatory Compliance

Documentation Control

CAPA

Audit Leadership

Educación

Bachelor's degree in chemistry/biology/microbiology

Advanced degree preferred

Herramientas

TEEXMA LIMS

Empower

Chromeleon

Descripción del empleo

Fagron is seeking a Quality Assurance Manager to lead the on-site Quality Unit for FAS. You will own the quality systems, data review, and disposition of laboratory testing, operating independently of bench work and reporting to the Quality Leader, FSS North America.

The role requires escalation of unresolved issues, CAPA ownership, and governance of document control and method validation packages. On-site position in a regulated lab environment.