Quality Control Compliance Specialist

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 

This role is responsible for ensuring compliance of QC Microbiology 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 Microbiology laboratory. The position requires minimal direction and involves analyzing procedures and managing change using creative solutions.

ESSENTIAL JOB DUTIES

• Support QC Microbiology regulatory inspection readiness.
• Supports, owns, authors, and drives QC Microbiology investigations, CAPA’s, CR’s, IAI’s and LIR’s to closure.
• Coordinates with quality systems and QC leadership to support on-time closure of quality records and represents QC Microbiology in relevant governance teams. 
   

ESSENTIAL RESPONSIBILITIES

• Create and update QC Microbiology SOPs, FRM’s, WOI and other GMP documents.
• Support proactive management of continuous improvement workstreams to drive operational efficiency and deviation reduction.
• Coach and collaborate with continuous improvement project owners.
   

FUNCTIONAL KNOWLEDGE

• Strong understanding of cGMPs and quality systems
• Knowledge and understanding of Lean Six Sigma and Human and Organization Performance (HOP) principles.
• Knowledge and understanding of Root Cause Analysis processes in a regulated environment.
   

TECHNICAL & LEADERSHIP SKILLS

• Demonstrated conflict resolution skills in a cross-functional setting with the ability to keep objectives on track.
• Demonstrated project management skills to accomplish deadlines and objectives.
• Demonstrated ability to drive change management.
• Ability to multi-task and work on various projects
• Ability to work with general direction and independently develop solutions.
• Strong oral and written communication skills
   

EDUCATION & EXPERIENCE

• BS/BA and 5-7+ years of experience, required;
• MS/MA and 2+ years of experience, preferred; or
• Equivalent education and experience may substitute for stated requirements. (List it)

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.