Quality Assurance Associate I

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 I, In Plant Operations, supports AGC Biologics operations by reviewing inputs, documentation and records required for manufacturing of biologic products. This may include Manufacturing Production Records, (MPRs), analytical test results (ie. data from QC related to manufacturing decisions), environmental and utilities data, equipment management records, documentation updates, as well as observation of the manufacturing process. The QA Associate supports the guided resolution of issues associated with batch manufacturing 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. PRINCIPAL RESPONSIBILITIES: Support the manufacture of biologics, on and off the plant floor, by providing QA support under guided direction 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. On the floor manufacturing support during operations. 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. Initiate and participate in process improvement activities for quality processes to enhance compliance and efficiency. 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. KNOWLEDGE, SKILLS & ABILITIES: Ability to work under general direction. Independently develop approaches to solutions for presentation to responsible party. Developing 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. Developing 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. Developing ability to interact with cross-functional teams 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: 0-2 years of relevant experience, BS/BA degree in Biology, Chemistry or other relevant discipline or equivalent work experience. SHIFT SCHEDULE: Sunday through Wednesday, 6:00am to 4:30pm COMPENSATION: $23.30 - $32.04 per hour 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.