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