Quality Assurance Associate III

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. SUMMARY: The QA Associate III, In Plant Operations, will support AGC Biologics operations by reviewing all inputs necessary to execute the disposition of the batches manufactured at the site. Such inputs may include: Master Production Record, (MPRs), analytical test results (i.e. Certificates of Analysis (COA)), environmental and utilities data, equipment management records, closure of deviations, assessments of Change Records, among others. It is expected from the QA Associate III to participate, lead as applicable, and provide guidance to other QAs in the solution of issues associated with production batches by interacting with cross-functional teams, supporting the implementation of solutions aligned with the cGMP regulations, AGC Biologics standards, and client expectations per corresponding Quality Agreements. This is a Sunday through Wednesday 8pm to 6:30am position. PRINCIPAL RESPONSIBILITIES: Support the manufacture of biologics, on and off the plant floor, by providing QA support to operations and compliance with cGMP, FDA, and ICH. Review of executed Master Production Records (MPRs), and other support documentation both on the plant floor and out-of-plant for completeness, compliance, and accuracy to support product lot disposition. Collaborate with stakeholders to resolve GMP errors. Review QC data generated from manufactured product and intermediates and approve results summaries. Support issuance activities for Master Production Records and other records, as needed. Review and approve preventative maintenance and repair work orders related to equipment or facilities. Review raw material testing for release to manufacturing operations. Initiate and participate in process improvement activities for quality processes to enhance compliance and efficiency, which may include revision of QA relevant SOPs and review and/or approval of site wide SOPs and other documents. Collaborate with manufacturing operations in the resolution of issues, non-conformities, and deviations. Act as the primary QA point-of-contact to escalate problem resolution to management and provide guidance for manufacturing activities to resume. Provide general support for other shifts, as needed, for activities from Manufacturing, Quality Control, and Engineering Operations. Expected to support trainings and qualifications May be required to provide guidance and support outside of assigned working hours KNOWLEDGE, SKILLS & ABILITIES: Ability to work in a team and independently as applicable to lead and develop approaches to solutions for presentation to responsible party. Technical and analytical understanding of Biologics Manufacturing and testing. Ability to clearly communicate compliance strategy and rationale via oral and written communication techniques. Good organizational skills. Working knowledge of regulatory and compliance principles and concepts as they relate to Manufacturing Operations. Ability to work on moderately complex problems where analysis of situations or data requires an in-depth evaluation of applicable factors. Ability to interact and lead when appropriate with cross-functional teams in order to ensure the compliance of the GMP operations at the site. Demonstrated strong understanding of procedures and methods for review function. Strong understanding of basic scientific/technical concepts. Comfortable working with Excel, Word, Power Point, MS Teams and various database type software. EDUCATION/EXPERIENCE: BS degree in Biology, Chemistry or other relevant discipline or equivalent work experience. Direct Quality Assurance experience preferred. 5 years of QA-related experience, including interpretation and application of regulatory principles which drive QA strategy. Advanced degree may partially substitute for work experience. Compensation: $74,960 - $103,070 Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. W ant to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.