Sr. GMP Training Specialist
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Sr. GMP (Good Manufacturing Practices) Training Specialist role exists to provide technical and GMP training proficiency and consultative guidance as a business partner to assigned Asset and/or Functional group. This position is a vital business partner who is passionate about training & committed to excellence while ensuring Lonza Portsmouth’s employees are properly trained prior to performance.
The role is the Asset and/or Functional Group POC (Point of Contact) for audit response, representing Technical & GMP Training during audits and inspections, or other emergent issues, consulting on curriculum development for new or modified roles, and leading strategic training projects. The Sr. Technical & GMP Business Partner will coach and mentor junior Technical and GMP Training Business Partners in an informal leadership capacity and is a role model in the organization, understanding and promoting GMP mindset and behaviors that drive a Quality Culture.
- Develop an ongoing Asset GMP Training Plan to define program deliverables, including justification for topics, measures of effectiveness to be used and an annual summary report.
- Coordinates and conducts needs assessment and performance analysis to determine GMP training needs (e.g. evaluation of Quality events, CAPAs, internal or external audit observations).
- Collaborates with supported Asset and/or Functional group to ensure business objectives are met through effective learning and training solutions.
- Applies adult learning and instructional design in the development and delivery of training modules in specialized technical and GMP topics.
- Executes Root Cause Analysis and corrective actions where a training solution is identified.
- Builds assessments and evaluations to measure progress and to evaluate effectiveness of GMP training programs.
- Conducts dynamic and interactive GMP classroom training sessions on a variety of topics.
- Develops training materials for use in training courses, with high attention to quality, role-specificity, and engaging learning experience, including the necessary storyboards, outlines, and project plans.
- Leverages knowledge of business and customers in order to identify SMEs and potential departmental trainers.
- Facilitates ‘Train The Trainer’ sessions.
- Consults with the Technical and GMP Training Back Office and reports issues impacting the quality, compliance and effectiveness of the Learning Management System (LMS).
- B.A. or B.S. Preferred area of study: Life Sciences or Education.
- Substantial experience in training/education
- Experience in a GMP environment or FDA-regulated industry, pharmaceutical or medical devices preferred.
- Instructional Design education or experience preferred.
- Experience with curricula development preferred.
- Detailed knowledge and understanding of adult learning theory and instructional design methodologies.
- Able to author training manuals and instructions, able to assess and recommend training needs and training assignments/requirements/curricula.
- Ability to lead cross-functional consultation on training strategy, strong facilitation and delivery skills, and ability to coordinate complex training initiatives.
- Skilled in coaching training and facilitation practices with the goal of improving training practices in others.
- Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding.
- Displays a clear willingness to listen to others. Has good interpersonal skills and works interdepartmentally in an effective manner to achieve objectives.
- Must be computer literate and able to effectively use the full MS Office suite of applications.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.