QA Associate II, Training Management

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 and cell and gene therapies. 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 QA Associate II, Training Management plays a key role in 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:

• Set up employee training in agreement with internal and regulatory requirements
• Maintain training documentation in the applicable employee files
• Collaborate with departments to ensure the applied training curricula commensurate with job duties and support annual training curriculum review
• Collaborate with departments to support optimization of training materials
• Ensure training documented on paper is applied in the electronic training management system
• Serve as point of contact for training enquiries from managers and employees
• Provide support for the development and maintenance of training procedures, work instructions, and templates
• May develop training materials and provide training, such as new hire orientation, GMP refresher training, etc.
• Perform trending on the GMP training system and generate site metrics
• Support regulatory inspections and client audit by providing training reports and applicable trending
• Identifies opportunities for improvement to the Training functions, as appropriate, and determines and develops approach to solutions
• Additional responsibilities not listed may be required of this position

KNOWLEDGE, SKILLS & ABILITIES:

• Understanding of CGMPs training requirements
• Experience with training management
• Excellent organizational skills and attention to detail
• Ability to work under general direction
• Experience in TrackWise preferred
• Ability to interact constructively with co-workers
• Understanding of basic scientific/technical concepts

EDUCATION/EXPERIENCE:

• BS/BA in relevant scientific discipline and 2-3 years' experience working in Training management in a GMP environment
• Equivalent education or experience may substitute for stated requirements

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.