Manager, Manufacturing OJT Training - Pharmaceutical

Paragon Bioservices   •  

Harmans, MD

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 113 days ago

The Manager, Manufacturing OJT Training will provide, document, and maintain, training for all manufacturing personnel on matters including but not limited to: new hire orientation, department and facility specific training.

Key Responsibilities include, but are not limited to:

  • Execute training at various skill levels for the department or subgroups related to Standard Operating Procedures (SOP) training, process training, and general on-the-job training sessions.
  • Generate, maintain and monitor training and competency records and databases for department personnel, ensuring that regulatory requirements for documentation are met.
  • Generate, update and maintain new hire and active employee CVs and central training file.
  • Coordinate with leadership while developing and implementing new training techniques, cross-train employees and maintain consistency concerning training documentation and procedures.
  • Assist the department with the maintenance of departmental Quality Management programs.
  • Ensure compliance of the training program / records.
  • Maintain and present training metrics.
  • Confer with leadership and team members to gain knowledge of work situations requiring technical training and to better understand changes in site SOP's, procedures, regulations, business initiatives and technologies.
  • Help co-ordinate training schedule with the hiring and training demands of the sites(s)
  • Conduct training sessions covering specified areas such as on-the-job training and refresher training.
  • Test trainees to measure progress and to evaluate effectiveness of technical training.
  • Report on progress of employees under guidance during training periods
  • Provides operational support for activities including (Ex. media/buffer preparation, cleaning activities, and equipment/materials staging/ Aseptic Technique).
  • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
  • Normally receives minimal instructions on routine work and detailed instructions on new assignments.
  • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices

Experience / Education

  • Bachelor degree in Science or Engineering field
  • 8 years’ experience in a GMP manufacturing or quality role with some or all of that time involved in training
  • Experience in mammalian cell culture and general Biologics manufacturing.
  • Ability to multi-task, excellent written and verbal communication skills, organizational skills, and attention to detail. Possess analytical thinking and problem-solving skills.
  • Demonstrated skills in the use of MS Office suite including, Excel, Word, PowerPoint and Access.
  • Demonstrated proficiency in delivering presentations

Requisition ID : 1125