Quality Assurance Associate III

Quality Assurance Associate III - 244917 Responsibilities On-site role providing QA oversight for manufacturing operations. Review and approve deviations, non-conformance events, change requests, and change controls. Audit and approve pre-/post-executed batch records, validation reports, and product/label specifications in compliance with cGMP and internal procedures. Prepare release checklists, CoAs, and related documentation to support timely batch disposition. Serve as QA liaison with manufacturing, project teams, clients, and regulatory bodies, ensuring quality standards are met and issues are appropriately escalated. Write, review, and revise SOPs; lead/participate in audits, inspections, walkthroughs, and process improvement initiatives. Represent QA in meetings and act as the single point of contact for designated clients. May perform qualified visual inspections of final product when required. Education & Experience 5+ years of experience in the biopharmaceutical industry Bachelor’s degree in a Science related field preferred Knowledge, Skills & Abilities Strong knowledge of FDA/EU cGMP requirements and QA documentation practices. Proficient with Microsoft Office; able to perform accurate calculations and data recording. Experienced in reviewing/approving deviations, NCEs, and change controls. Skilled in problem-solving, decision-making, and prioritizing competing tasks. Effective communicator with strong interpersonal and teamwork abilities. Flexible and adaptable to changing priorities and business needs. Demonstrated ability to work independently on complex issues while building productive internal/external relationships. Seniority level Associate Employment type Full-time Job function Quality Assurance Industries Biotechnology Research and Pharmaceutical Manufacturing #J-18808-Ljbffr