QA GMP Training Specialist
Catalent
 Harmans, MD

Job Description

Position Overview:

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

QA GMP Training Specialist

Position Summary

Catalent Paragon Gene Therapy is looking to recruit a GMP Training Specialist to join our growing team in Harmans, 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.

The GMP Training Specialist role is critical to our patients. The specialist are the first in the development of qualified cGMP professionals leading our journey in development and manufacturing of quality products and processes with patient safety in mind, executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role!

The Role

  • 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

The Candidate

  • 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
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Position Benefits

  • 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

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.