Quality Assurance Training Specialist

Location
Harmans, MD, US
Posted
Aug 05, 2019
Ref
1564
Hotbed
BioCapital
Required Education
Masters Degree/MBA
Position Type
Full time
Paragon Gene Therapy, now a part of Catalent, 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.

Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

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 is an experienced educator who's abilities to convey a message should only be surpassed by a deep knowledge of your field. Organizational skills and a positive attitude are important qualities that this individual must possess.
The goal of the GMP Training Specialist is to promote efficiency and competitive advantage by developing the skills of personnel. The GMP Trainer is also responsible for maintaining the lifecycle of the Quality Assurance Training Program and evaluating for continuous improvement.

Shift work and/or weekend work may be required at times.

Key Roles & Responsibilities include but are not limited to:

  • 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
  • Select and book venues
  • Conduct seminars, workshops, individual training sessions, etc.
  • Prepare educational material, such as, module summaries, videos, etc.
  • Support and mentor new employees
  • Keep attendance and other records
  • Maintain databases and systems to track required training records
  • Conduct evaluations to identify areas of improvement
  • Monitor employee performance and response to training
  • Assist processing and maintaining employee training files
  • Assist with the corporate implementation of a selected learning management system

Experience & Education:

  • 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.
  • 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
  • Experience supporting regulatory CGMP, ICH and EU compliance is a plus

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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