QA Supervisor, Product Release

Job Summary and Purpose

The QA Supervisor, Product Release is responsible for supervising and coordinating product release activities for Animal Health Biological vaccines, including documentation review, labeling verification, warehouse release operations, and final product disposition. This role ensures that product release processes are executed in compliance with applicable regulatory requirements, including USDA regulations, 9 CFR, other international requirements, and internal Standard Operating Procedures (SOPs).

Responsibilities and Key Duties

• Supervise and support Product Release personnel, promoting a collaborative, compliant, and quality-focused work environment.
• Cover daily product release activities to ensure timely and compliant reviews, disposition, and release of materials and finished products.
• Review and support the accurate and timely submission of serials to the USDA in accordance with applicable regulatory requirements.
• Perform and supervise the review of batch records, production documentation, and quality records to ensure completeness, accuracy, and compliance with established procedures.
• Support the investigation of deviations, discrepancies, and quality events, ensuring appropriate documentation and timely resolution to facilitate product release decisions.
• Maintain accurate material status and data integrity within quality and inventory management systems, including JD Edwards (JDE).
• Review and approve Certificates of Analysis and other product release documentation to ensure accuracy and compliance.
• Collaborate with Regulatory Affairs, Manufacturing, Quality Control, Supply Chain, and other stakeholders to ensure all release requirements are satisfied prior to product disposition.
• Supervise warehouse release activities, including review and approval of product shipments, maintenance of product status, and compliance with Good Distribution Practices (GDP), cold chain requirements, and export documentation requirements.
• Monitor product release metrics, identify process improvement opportunities, and escalate issues that may impact product availability, compliance, or customer commitments.
• Support internal and external audits and inspections by providing documentation, responding to inquiries, and assisting with the implementation of corrective actions as needed.
• Provide training, coaching, and performance feedback to Product Release personnel to ensure continued development and compliance with quality standards.

Qualifications

• Bachelor's degree in Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline required.
• Minimum of 5 years of experience in Quality Assurance, Quality Control, or related quality functions within biologics, pharmaceutical, biotechnology, or veterinary vaccine manufacturing required.
• Demonstrated experience coordinating quality activities, reviewing GMP documentation, and supporting product release or disposition processes required.
• Previous experience supervising, leading, mentoring, or training personnel is preferred.
• Experience working in a regulated environment with knowledge of applicable regulations, including USDA, 9 CFR, GMP, and other relevant regulatory requirements preferred.
• Knowledge of USDA veterinary biologics regulations, including 9 CFR requirements and product release processes preferred.
• Proficiency with ERP, LIMS, and electronic quality management systems.
• Strong leadership, communication, organizational, and problem-solving skills.
• ASQ certifications (CQA, CQE, CMQ/OE) and/or Lean Six Sigma certification preferred.