Catalent Pharma Solutions: Quality Assurance GMP Training specialist
Posted By: Maima Kamara on November 12, 2020 |
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Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
GMP Training Specialist
Catalent Gene Therapy is looking to recruit a GMP Training Specialist to join our growing team in Baltimore, MD.
The GMP Training Specialist is a member of the Quality Assurance Training Program of a Contract Development & Manufacturing Organization (CDMO) performing research, process development and GMP manufacture of biologic bulk drug substances and sterile finished products. The core responsibility is to help GMP employees cultivate their skills and knowledge to maintain regulatory compliance. This role is also responsible for developing and providing training presentations with subject matter experts on relevant topics, providing measures to ensure complete understanding/proficiency, and performing/coordinating remedial training as applicable.
Catalent Gene Therapy hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love.
Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.
Provide strategic oversight of the training program and system.
Liaise with all department management at Paragon to determine training needs, establish training curriculums and assignments based upon work functions, and schedule training sessions.
Develop and deliver training presentations on pertinent topics to large groups of personnel on an as needed basis, including new employee orientation, annual refresher training, remedial training and on as a needed basis to support the production schedule. Examples include, but are not limited to, current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), Aseptic Processing, Client Confidentiality Training.
Design effective training programs
Conduct seminars, workshops, individual training sessions, etc.
Prepare educational material, such as, module summaries, videos, etc.
Maintain databases and systems to track required training records and monitor employee performance and response to training
Perform administrative activities with MasterControl LMS system
B.S. in a Life Sciences discipline and 8+ years of experience within the biologic, pharmaceutical or medical device industry with responsibilities for developing or delivering training to colleagues and/or managing a training program OR M.S. in a Life Sciences discipline and 4+ years of experience within the biologic, pharmaceutical or medical device industry with responsibilities for developing or delivering training to colleagues and/or managing a training program.
Experience supporting regulatory CGMP, ICH and EU compliance is a plus
Familiarity with electronic systems, including PowerPoint, Excel and Master Control Learning Management System
Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
Catalent’s standard leadership competencies that are used to interview and for Performance & Development
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Potential for career growth within an expanding team
Defined career path and annual performance review & feedback process
Cross functional exposure to other areas of within the organization
Medical, Dental, Vision, and 401K are all offered from day one of employment
19 days of paid time off annually + 7 paid holidays
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