Manufacturing Training Specialist II
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 Manufacturing Training Specialist II acts as a liaison with Manufacturing, Quality Assurance, and the Quality Systems GMP Training Department regarding training content, delivery and metrics and ensures that activities are appropriately tracked in the Learning Management System. The Manufacturing Training Specialist role provides technical proficiency and consultative guidance as a business subject matter expert (SME) in the creation of On-The Job training materials. This position is a vital business partner who is passionate about training & committed to excellence while ensuring Manufacturing and Technical Operations personnel are properly trained prior to performance.
PRINCIPAL RESPONSIBILITIES:
- Understand and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.
- Collaborates with Manufacturing, Quality Assurance, and the Quality Systems GMP Training department, developing training materials for use in training courses, with high attention to quality, role-specificity, and engaging learning experience (e.g. videos, computer based training, wiki, websites, LQMs, trainee and trainer manuals, job aids, etc.) and any other general information intended to expedite on-boarding and development of personnel.
- Acts as the liaison working in collaboration with the Manufacturing, Quality Assurance, and the Quality Systems GMP Training department regarding:
- Training completion and training compliance metrics/KPls ensuring that activities are appropriately tracked in the LMS.
- Regular meetings with trainee, trainer, Technical & GMP Training team and supervisor to discuss progress and issues.
- Curricula management and coordination with Manufacturing and Technical Operations employees.
- Acts as Manufacturing's POC (Point of Contact) for consulting on curriculum development for new or modified roles, and cross-department training projects.
- Ensures training plan objectives are met through effective learning and training solutions.
- Participate in training-related deviation investigations
- Support of internal/external audits for the Manufacturing and Technical Operations departments as needed.
- Communicate statuses, risks, and timelines effectively to management.
- Serve as a role model in the organization, understanding and promoting GMP mindset and behaviors that drive a Quality Culture.
- Coordinate dynamic and interactive GMP and/or safety, classroom and/or On-The Job (OJT) training sessions and any other topics as needed.
Must KNOWLEDGE, SKILLS & ABILITIES:
- Detailed knowledge and understanding of biopharmaceutical manufacturing processes and related equipment
- Strong understanding and ability to apply GMP requirements as they relate to manufacturing operations and quality management systems
- Application of adult learning theories, training facilitation, and delivery preferred.
- Effectively presents information, concepts, and training materials in various modes in a manner that facilitates understanding.
- Displays a clear willingness to listen to others.
- Ability to work interdepartmentally effectively with good interpersonal skills
- Shows commitment and dedication and strives to be ahead of schedule.
- Practices safety awareness at all times and considers impact of actions prior to executing activities.
- Passionate for training and to train others.
- Must be computer literate and able to effectively use the full MS Office suite of applications
EDUCATION/EXPERIENCE:
- A. or B.S. in scientific discipline (such as Chemistry/Biology) or Education required
- 2 - 4+ years of GMP biotechnology/pharmaceutical industry experience required
- Previous experience delivering technical training within GMP biotechnology/pharmaceutical industry preferred
- Experience using quality management systems software (e.g. TrackWise) required
- Equivalent education and 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