QA Associate

Job Description

This QA Associate supports the review and analysis of data related to product and packaging quality, ensuring compliance with cGMP standards, written procedures, and applicable regulations. This role provides quality systems support, partners closely with production, supply chain, QC laboratories, and customer service, and plays a key role in batch record management, material approval, and quality documentation for animal health and nutrition products.

QA Associate

• Support quality systems by organizing, critically reviewing, and presenting information in accordance with written procedures and cGMP standards.
• Provide day-to-day quality support for production areas to help ensure compliant manufacturing operations.
• Apply or obtain statistical analysis to support quality-related decisions and data evaluation.
• Write, review, and revise GMP standard operating procedures to maintain accurate and compliant documentation.
• Track, maintain, critically review, and correct manufacturing records (tickets), and print additional documentation to include with manufacturing records for disposition.
• Maintain communication with the QC laboratory regarding test results that are pertinent to batch release, ensuring timely and accurate information flow.
• Maintain communication with Supply Chain representatives to ensure batch manufacturing records are released in a timely manner.
• Approve raw materials for use in production areas by evaluating vendor Certificates of Analysis (COAs), printing permits, approving materials as they arrive on site, blocking and unblocking material as needed, and tracking vendor information on a shared site for visibility.
• Maintain communication with material coordinators to ensure awareness of materials received on site and materials urgently needed in production areas.
• Print and prepare batch manufacturing records as requested by Supply Chain, including manually printing product shipping labels, verifying count and variable data information, tracking and creating additional labels as needed, and coordinating timely pick up and drop off of records and labels.
• Create or prepare Certificates of Analysis (COAs) as requested by Customer Service representatives, including creation of AQIS documents and permits, updating health and non-radiation certifications, and creating Certificates of Manufacturing and Certificates of Conformity.
• Track COA requests, create irregular COAs and COA templates, and mail documents to Customer Service representatives while maintaining communication to ensure timely delivery of Certificates of Analysis to the destination country.
• Perform inbound quality analysis and receipt for printed packaging materials, and approve printed packaging materials for use in production areas.
• Monitor temperature records of bulk material received for companion animal products to ensure proper storage and handling.
• Approve bulk material received for companion animal products based on quality and compliance criteria.
• Own, track, and route documents in Veeva Vault for edit, review, and approval as needed for Quality Assurance and Technical Service/Manufacturing Science representatives.
• Ensure quality documentation, including SOPs, batch records, and certificates, is accurate, complete, and maintained in a highly regulated environment.
• Conduct QA checks and QA tests as needed, supporting laboratory and analytical activities such as titration and pH testing, where applicable.
• Contribute to continuous improvement of quality processes by identifying documentation or workflow issues and collaborating on solutions.

• Bachelor’s or Associate’s degree in a related field, or no degree with at least 12 months of QA or GMP experience.
• Demonstrated experience working in a GMP, pharmaceutical, life science, or highly regulated quality environment.
• Strong communication skills, with the ability to maintain clear, timely communication with QC, Supply Chain, Customer Service, and other stakeholders.
• Strong documentation skills, including accurate recordkeeping, SOP review, and quality documentation management.
• Solid math skills to support data analysis, statistical evaluation, and verification of counts and variable data.
• Proficiency with computers, including working with electronic document systems such as Veeva Vault and shared sites.
• High attention to detail and the ability to work effectively in a highly regulated environment with strict procedures.
• Experience with batch record review and batch record maintenance.
• Knowledge of cGMP principles and quality assurance practices.
• Ability to perform QA tests, QA checks, and QA documentation tasks in a laboratory or production support setting.

• Experience in biology, chemistry, or a related scientific discipline is beneficial.
• Experience with quality inspection and quality documentation in a manufacturing or laboratory setting.
• Familiarity with laboratory techniques such as titration and pH testing.
• Experience…