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. AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com. SUMMARY: The Quality Assurance (QA) Scientist I-III will provide quality oversight of the Quality Control (QC) department to ensure compliance with all standards, procedures, and regulations. Responsible for the QA review and approval of SOPs, Methods, Deviations, Laboratory Investigations, Change Controls, Method Validation and Equipment Qualification activities related to the QC department. May lead projects or represent QA interests in multidisciplinary project teams. KEY RESPONSIBILIES: Provide QA oversight for quality control activities, including review/approval of methods, stability protocols/reports, and certificate of analyses. Supports the QA review and approval of method validation, method transfer, and equipment qualification activities related to the quality control laboratories. Acts as QA approver for quality system records, such as Change Controls, Deviations, CAPA and Laboratory Investigations. Partners with QC and other departments for root cause analysis, problem solving and implementing corrective and preventive actions. Demonstrates success using compliance knowledge, creativity and regulatory perspectives to solve problems. Accountable for decisions and results that ensure timelines are met. Responsible for making recommendations in accordance with federal and international regulatory requirements and industry standards. Works closely with other team members in a cooperative fashion to ensure project progression. May participate in internal/external audits and regulatory inspections. Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance. KNOWLEDGE, SKILLS & ABILITIES: Understanding of Biologics Manufacturing and Quality Control Testing in a GMP facility. Knowledge of scientific principles and concepts as they relate to Quality Control and GMP. Knowledge of CAPA, change control and deviation programs and requirements. Great team player who is collaborative and positive. Ability to understand and apply GMP regulations as they relate to QC and Quality Systems. Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated. Strong interpersonal, written/oral communication and problem solving skills. Experience with regulatory inspections, internal/external audits. EDUCATION/EXPERIENCE: Degree in Life Sciences or Engineering and prior QA-related experience or equivalent work experience, dependent on level; Scientist I – BS/BA with 5 years, MS/MA with 2 years, PhD with 0-2 years Scientist II – BS/BA with 7 years, MS/MA with 5 years, PhD with 2 years Scientist III – BS/BA with 10 years, MS/MA with 8 years, PhD with 5 years COMPENSATION RANGE: $83,920 - $148,610 Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities. Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave. Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance. 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. 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. Want 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. 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.