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
The QC Compliance Specialist is responsible for ensuring compliance of QC SOPs and quality records with regulatory guidelines. It requires attention to detail, organization, multi-tasking, and the ability to interact with people of varying seniority levels. Responsibilities include internal and external audit support, handling complex problems with in-depth analysis, and interacting cross-functionally. This role coordinates compliance related workstreams with continuous improvement efforts to maintain efficient and compliant operations of the QC laboratory. The position requires minimal direction and involves analyzing procedures and managing change using creative solutions.
ESSENTIAL JOB DUTIES & RESPONSIBILITIES
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Support QC regulatory inspection readiness
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Supports, owns, authors, and drives QC investigations, CAPA’s, CR’s, IAI’s and LIR’s to closure.
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Coordinates with quality systems and QC leadership to support on-time closure of quality records and represents QC in relevant governance teams
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Create and update QC SOPs, FRM’s, WOI and other GMP documents
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Support proactive management of continuous improvement workstreams to drive operational efficiency and deviation reduction
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Coach and collaborate with continuous improvement project owners
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Other duties, as assigned.
TECHNICAL & LEADERSHIP SKILLS
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Strong understanding of cGMPs and quality systems
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Knowledge and understanding of Lean Six Sigma and Human and Organization Performance (HOP) principles
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Knowledge and understanding of Root Cause Analysis processes in a regulated environment
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Demonstrated conflict resolution skills in a cross-functional setting with the ability to keep objectives on track.
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Demonstrated project management skills to accomplish deadlines and objectives.
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Demonstrated ability to drive change management
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Ability to multi-task and work on various projects
EDUCATION & EXPERIENCE
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Bachelor’s degree in Biology, or a related science field with 5-7+ years of relevant experience
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Equivalent education and experience may substitute for stated requirements
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QC laboratory and quality management system (MasterControl, TrackWise, etc.) experience preferred
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. 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.
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What We Do
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics (using mammalian and microbial systems), mRNA, pDNA, viral vector and cell therapy products, from pre-clinical to commercial production, including our proprietary CHEF1TM Expression System for efficient protein production with CHO cells. Our company DNA drives us to provide innovative solutions to partner with our customers in helping them reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle. We forge exceptionally strong partnerships with our customers and we never lose sight of our commitment to deliver reliable and compliant drug substance. Visit www.agcbio.com to learn more.
