GMP QA Manager — Batch Release & Compliance

Axiota US Inc; Wamego (KS); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401K retirement plan

Paid time off

Paid holidays

Bonus

Job summary

Axiota is seeking a Quality Assurance Manager in Wamego, KS to establish and continually improve the site quality system, ensuring GMP compliance and regulatory readiness for manufacturing operations.

You will lead the QA team, oversee batch release, documentation, audits, training, and investigation of complaints, collaborating with Production, QC, R&D, Engineering, Maintenance, and Logistics to drive product quality and continuous improvement.

Qualifications

• 3–5 years of experience in Quality in a GMP facility, with leadership experience.
• Experience with or strong understanding of microbial fermentation processes.
• Bachelor’s degree in Chemistry, Biology, Biochemistry, Engineering, or a related scientific discipline.
• Strong interpersonal skills with internal and external stakeholders.

Responsibilities

• Ensure production and support functions conform to Good Manufacturing Practices.
• Perform batch release function for finished products.
• Maintain product quality by implementing a quality system that meets regulatory requirements.
• Ensure that all procedures, processes, and facilities conform to quality system requirements.
• Manage the documentation system by writing, updating, reviewing, and approving SOPs and Master Manufacturing Documents.
• Manage the training program by collaborating with Production, Quality Control, Maintenance, Logistics, and R&D.
• Manage all internal and external audits (FDA, APVMA, and others) and ensure written responses are tracked and submitted.
• Investigate, evaluate, and trend customer complaints for regulatory and continuous improvement purposes.
• Approve product and process quality reports (CAPAs, change controls, deviations, complaints).
• Prepare Quality Assurance reports (trend analyses) on a weekly, monthly, or annual basis.
• Collaborate to establish quality standards for production processes, testing methods, and material specifications.
• Provide Quality guidance and expertise for multiple departments.
• Manage the QA team's workload and develop talent.
• Stay current with the latest Quality requirements.

Skills

GMP Experience

Leadership

Microbial Fermentation

Quality Assurance

Education

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

Job description

Axiota is seeking a Quality Assurance Manager in Wamego, KS to establish and continually improve the site quality system, ensuring GMP compliance and regulatory readiness for manufacturing operations.

You will lead the QA team, oversee batch release, documentation, audits, training, and investigation of complaints, collaborating with Production, QC, R&D, Engineering, Maintenance, and Logistics to drive product quality and continuous improvement.