Release Operation Representative Jobs (NOW HIRING)

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).

The position provides day-to-day supervision of Product Release personnel and supports the timely review and approval of production, laboratory, and quality documentation to facilitate compliant product release and submission of serials to the USDA. The QA Supervisor also oversees warehouse-related quality activities to ensure products are appropriately released, controlled, and distributed in accordance with established quality and regulatory requirements.

Working closely with Manufacturing, Quality Control, Regulatory Affairs, Supply Chain, and Warehouse Operations, the QA Supervisor supports the resolution of quality issues, promotes continuous improvement, and helps maintain inspection readiness and continuity of supply.

Through effective supervision, technical expertise, and a risk-based quality approach, this role contributes to product quality, regulatory compliance, operational efficiency, and the reliable supply of products to customers.

Responsibilities and Key Duties:

• Supervise and support Product Release personnel, promoting a collaborative, compliant, and quality-focused work environment.
• Coordinate 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.
• Perform other duties as assigned.

Core Competencies:

        Shape solutions out of complexity - Is open and curious of other perspectives

        Client focus - Has in mind client's satisfaction

        Collaborate with empathy - Has a positive attitude towards collaboration

        Engage and develop - Clarifies short-term directions

        Drive ambition and accountability - Proactively manages own and others' work

        Influence others - Communicates transparently

Technical / Functional Competencies:

        Audit & Inspection Readiness - Ability to support internal and external audits and represent Product Release during regulatory inspections.

        Technical Expertise - Understanding of biologics/vaccine manufacturing, quality control, and risk-based decision making.

        Continuous Improvement - Ability to identify process improvements and apply risk-based approaches to enhance efficiency and compliance.

        Regulatory Knowledge - Familiarity with 9 CFR, GMP, and global regulatory requirements.

        Systems & Digital Tools - Proficiency in enterprise and quality systems (e.g., JD Edwards, QMS, document management).

        Quality Systems (QMS) - Knowledge of deviations, CAPA, change control, and documentation practices.

Qualifications:

Education and Experience

        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.

Other Qualifications

• 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.

Physical Requirements:

        Ability to read, write legibly and communicate in English

• Capable of working extensively with computers
• Tasks frequently require prolonged mental and visual concentration
• Position will require bending, twisting, lifting and standing
• Ability to travel between different areas and buildings

Working Conditions:

• Based at the Biomune Lenexa campus, with responsibilities across multiple buildings.

Travel Required:

        Occasional travel required based on business needs, including support for audits, inspections, and cross-site collaboration.

This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job.  This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job.  This job description is not an employment contract.  Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.

*VEVRAA Federal Contractor
**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.

669B