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.
- 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.
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.
