Quality Assurance Training Coordinator

Location
Harmans, MD, US
Posted
Aug 05, 2019
Ref
1650
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.

This position is a member of the Quality Assurance Unit and is responsible for managing the Training Program of a CDMO performing research, process development and GMP manufacture of biologic bulk drug substances and sterile finished drug products. The core responsibility is the day-to-day management of the training tracking system, as well as serving as the primary resource for Pre-Clinical and GMP personnel managing their training in conjunction with their Supervisor/Manager. The Training Coordinator 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 where needed. The Training Coordinator is also responsible for maintaining the life cycle of the Quality System Training Program and evaluating for continuous improvement.

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

Key Responsibilities include but are not limited to:

  • Facilitates Paragon Training and Tracking System, ensuring Pre-Clinical and GMP personnel are appropriately and adequately trained to perform their assigned function to a high level of competence, regulatory compliance and efficiency.
  • Work directly with all levels and departments at Paragon to establish training curriculums and assignments based on assigned functions.
  • Process and maintain file system for training records.
  • Ensure critical procedures have appropriate mechanisms to demonstrate comprehension and understanding. The Training Coordinator will work with applicable functions to assist in development of technical training materials.
  • Maintain system to track required training and qualifications
  • Ensure the timely and accurate retrieval of personnel training and qualifications.
  • Liaison with Document Control and other functional departments to coordinate training on new or revised procedures.
  • Evaluate, develop and implement improvements to current training tracking system.
  • Work with clients and Project Management to support the success of manufacturing campaigns as needed
  • Maintain databases and systems used for tracking various GMP manufacturing associated support activities
  • Develop and deliver training presentations on pertinent topics to personnel on an as needed basis
  • Assist with the generation and/or revision of GMP documentation such as standard operating procedures
  • Support regulatory (FDA, EMA) and client audits/inspections of Paragon
  • Assist with performing internal audits
  • Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards

Education & Experience:

  • HS/GED required; AS in a science, engineering or quality management preferred
  • 2+ years of experience in a role where the coordination of training was a prevalent responsibility
  • Experience in a regulated environment required
  • Familiarity of cGMP regulations, quality systems and regulatory requirements preferred
  • Proficiency with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc) preferred
  • Advanced skills with MS Office applications with special focus on Excel and Access databases as well as Adobe Acrobat required


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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