Quality Assurance Associate II

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. JOB SUMMARY Support AGC Biologics operations by reviewing all inputs necessary for disposition of batches manufactured at the site in compliance with applicable regulatory guidelines and requirements, as well as creation and review of Drug History Record documents. ESSENTIAL JOB DUTIES/RESPONSIBILITIES Review executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition and partners with others for corrections as necessary Review QC data generated from manufactured product and intermediates; approves results summaries Create and review documents to be included in DHRs Identify and triage deviations Participate in interdepartmental discussions or meetings, as needed Communicates basic and moderately complex concepts. Interacts with others to inform and provide suggestions for action. Support in-plant operation, if necessary, by conducting in-plant review of MBRs and providing QA support for operations. KNOWLEDGE, SKILLS & ABILITIES Strong understanding of GMP and GDP principles Understanding of basic scientific/technical concepts. Ability to work on moderately complex problems and explain logic or decisions to others. Ability to work under only general direction. Independently determines and develops approach to solutions. Exchanges ideas and content in a clear manner. QUALIFICATIONS Required : BS degree, preferably in Biology, Chemistry or other relevant discipline and 2 years of relevant experience. Equivalent education and experience may substitute for stated requirements. COMPENSATION $28.73 - $39.50/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.