GMP QA Leader – Batch Release & Compliance Growth

Axiota; Wamego (KS); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) with match

FSA

HSA

Employee Assistance Program

Paid time off

Paid holidays

Job summary

Axiota is seeking a Quality Assurance Manager for its facility in Wamego, KS. The role leads the QA team, ensures GMP compliance, and oversees batch release, documentation, audits, and CAPAs while collaborating with Production, QC, Engineering, R&D, and Logistics.

The ideal candidate has 3–5 years in GMP quality with leadership, and a strong understanding of fermentation processes. Axiota offers comprehensive benefits and opportunities for continuous improvement at the site.

Qualifications

• 3–5 years of experience in Quality in a GMP facility with leadership experience.
• Experience with microbial fermentation understood or hands-on.
• Bachelor’s degree in a relevant science or engineering discipline.
• Strong interpersonal skills with internal and external stakeholders.

Responsibilities

• Oversee batch release and documentation control.
• Maintain and improve quality systems to meet GMP and regulatory requirements.
• Manage internal and external audits (FDA, regulatory bodies) and respond to findings.
• Develop QA team and provide quality guidance to cross-functional teams.
• Write, update, review, and approve SOPs and Master Manufacturing Documents.

Skills

GMP leadership

Fermentation processes

Interpersonal skills

Education

Bachelor's degree in Chemistry, Biology, Biochemistry, Engineering, or related

Job description

Axiota is seeking a Quality Assurance Manager for its facility in Wamego, KS. The role leads the QA team, ensures GMP compliance, and oversees batch release, documentation, audits, and CAPAs while collaborating with Production, QC, Engineering, R&D, and Logistics.

The ideal candidate has 3–5 years in GMP quality with leadership, and a strong understanding of fermentation processes. Axiota offers comprehensive benefits and opportunities for continuous improvement at the site.