Quality Assurance Manager

Axiota Animal Health; Wamego (KS); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) with match

FSA

HSA

EAP

Paid time off

9 paid holidays

Job summary

Axiota Animal Health is seeking a Quality Assurance Manager to establish, maintain, and continuously improve GMP-compliant quality systems for the manufacturing facility. You will lead batch release, documentation control, audits, training, and investigations while partnering with Production, QC, Engineering, R&D, Maintenance, and Logistics.

You will manage the QA team, develop talent, stay current with regulatory expectations, and drive continuous improvement across processes and materials.

Qualifications

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

Responsibilities

• Oversee GMP compliance for manufacturing operations.
• Perform batch release for finished products.
• Maintain quality systems and drive continuous improvement.
• Manage documentation and SOPs.
• Lead audits (FDA, APVMA, others) and responses.
• Lead QA team development and training.
• Collaborate with Production, QC, R&D, and others.

Skills

Leadership experience

GMP knowledge

Interpersonal skills

Education

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

Job description

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.
• Maintain 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.
• Other duties as assigned.

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 which include medical, dental, vision, life insurance, 401K retirement plan w/match FSA, HSA, EAP, short-term and long-term disability, paid time off, and 9 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.