Quality Assurance Manager

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Assurance Manager

Full Time Clerical MS Biotec Technology Center - Wamego, KS, Wamego, KS, US

Position Summary

The Quality Assurance Manager is responsible for establishing, maintaining, and continuously improving the quality systems that govern manufacturing operations at the facility, ensuring full compliance with Good Manufacturing Practices (GMP) and applicable regulatory requirements (FDA, APVMA, and other relevant bodies). This role oversees batch release, documentation control, training, audit management, and complaint investigation, while partnering closely with Production, Quality Control, Engineering, R&D, Maintenance, and Logistics to uphold product quality and drive continuous improvement. The QA Manager also leads and develops the Quality Assurance team, serving as the site’s subject matter expert on quality standards and regulatory expectations.

Key Responsibilities

• Ensure production and support functions (materials management, equipment, calibrations, validations, etc.) conform to Good Manufacturing Practices.
• Perform batch release function for finished products.
• M aintain product quality by implementing a quality system that meets regulatory requirements, and continuously improve quality processes and systems.
• Ensure that all procedures, processes, and facilities conform to quality system requirements.
• Manage the documentation system by writing (as needed), updating, reviewing, and approving all Standard Operating Procedures and Master Manufacturing Documents.
• Manage the training program by collaborating with Production, Quality Control, Maintenance, Logistics, and R&D to identify and develop needed training.
• Manage all internal and external audits (FDA, APVMA, and other relevant regulatory bodies) and ensure written responses are tracked and submitted as committed.
• Investigate, evaluate, and trend customer complaints for both regulatory and continuous improvement purposes.
• Approve product and process quality reports (production or quality control paperwork as needed; CAPAs, change controls, deviations, complaints, etc.).
• Prepare Quality Assurance reports (trend analyses) on a weekly, monthly, or annual basis, as needed.
• Collaborate with Production and Quality Control to establish quality standards for production processes, testing methods, quality control procedures, and specifications for raw materials, in-process product, and finished product.
• Provide Quality guidance and expertise for Production, Engineering, R&D, Quality Control, and other departments as needed.
• Manage the Quality Assurance team's workload and develop talent within the organization.
• Maintain and expand professional and technical knowledge by staying current with the latest Quality requirements.

Skills / Qualifications

• 3–5 years of experience in Quality in a GMP facility, with previous 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 both internal and external stakeholders.

Axiota offers a competitive base salary plus bonus and benefits packages, including medical, dental, vision, life insurance, 401K retirement plan with match, FSA, HSA, EAP, short-term and long-term disability, paid time off, and paid holidays.

Axiota is an Equal Opportunity Employer. We strive to foster a culture of respect and seek to empower each individual. All employment decisions are based on merit, qualifications, experience, and abilities. This employer uses E-Verify.