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 GMP Training Specialist is key to ensuring that we meet the compliance, regulatory guidelines and expectations of our clients. This role requires attention to detail, organization, multi-tasking, and comfort interacting with people who might be junior or senior to the incumbent.PRINCIPAL RESPONSIBILITIES:* Drives the delivery of the GMP Training program and schedule.* Works with the Quality Training Supervisor to ensure the GMP Training program contents meet regulatory requirements and interpretations while meeting operational needs.* Issues training reports to measure compliance with program requirements.* Identifies opportunities for improvement to optimize the GMP Training program.* Actively participates in cross-functional and inter-site training improvement projects.* Provides support to other functional areas for dealing with human error non-conformances.* Independently determines and develops approach to solutions.* Additional responsibilities not listed may be required of this position.KNOWLEDGE, SKILLS & ABILITIES:* Exhibits a high level of initiative and the ability to maintain composure.* Displays intellectual curiosity.* Experience in Trackwise.* Deep understanding of CGMPs.* Demonstrated ability to multi-task and work on several QA projects and problems.* Ability to participate and lead group and individual training sessions.* Ability to work under general direction.* Experience/background in Quality and GMP is highly desirable.* Understanding of basic scientific/technical concepts.* Good analytical skills.* Clear, concise writing skills.* Good verbal presentation skills.* Excellent organizational skills and attention to detail.* Ability to interact constructively with co-workers.EDUCATION/EXPERIENCE:* BS/BA in relevant discipline or combination of education and equivalent work experience.* 2-3 years' experience working in the regulated industry (GLP, GCP or GMP) required.* Experience working with LMMS, Trackwise, Mastercontrol, Agile, or similar system.* Must have proven ability to deliver training session* Experience developing training materials a plus.* Equivalent education or experience may substitute for stated requirementsAGC 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.
Location/Region: Bothell, WA (98021)