Inspection Operations Training Specialist

INCOG BioPharma Services•Fishers, IN

11d•Onsite

About The Position

INCOG Biopharma Services is hiring a department Training Specialist for the Inspection Operations team. The training specialist will be responsible for the development, coordination and the execution of the training programs for departmental employees. The specialist will maintain training records and test trainees to measure progress and evaluate effectiveness of training. Additionally, the specialist will develop an onboarding training platform to ensure consistent timely training opportunities for new hires within the operations department. Essential Job Functions: Identify and develop best practices/ SOPs to improve efficiency. Directs or conducts OJT’s studies to ascertain the best sequence of operations or workflow. Review employees training and partner with operations to develop action plans to improve and create OJT’s. Recommends methods to ensure the maximum utilization of equipment uptime and minimize equipment downtime. May assist in establishing accident prevention measures. Maintain effective communication with other departments and employees. Function effectively at both strategic and tactical levels. Proven leadership skills including the ability to coach, assess, evaluate, develop, motivate, and empower others. Strong change management skills to challenge the status quo and drive improvements. Ability to display “leadership by example” management style and work ethic. Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external clients. Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment. Ability to work with and influence peers and senior management. Self-motivated with critical attention to detail, deadlines and reporting. Participate and support equipment/process FMEAs to understand process and product risks. Participate and report to a cross-functional team to advance training activities and initiatives. Work flexible hours for the coverage of training needs.

Requirements

5+ years of experience with creating Training modules/ documentation/ templates.
2+ years of OTJ training of teams, including hands-on quality inspection training.
Practical expertise with GxP manufacturing and regulatory requirements for pharmaceuticals and EHS.
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, inspection/packaging operations and process development.
Must have knowledge and understanding of inspection processes and technique.
Must have excellent interpersonal and communication skills as well as exhibit initiative and a high level of energy.

Responsibilities

Identify and develop best practices/ SOPs to improve efficiency.
Directs or conducts OJT’s studies to ascertain the best sequence of operations or workflow.
Review employees training and partner with operations to develop action plans to improve and create OJT’s.
Recommends methods to ensure the maximum utilization of equipment uptime and minimize equipment downtime.
May assist in establishing accident prevention measures.
Maintain effective communication with other departments and employees.
Function effectively at both strategic and tactical levels.
Proven leadership skills including the ability to coach, assess, evaluate, develop, motivate, and empower others.
Strong change management skills to challenge the status quo and drive improvements.
Ability to display “leadership by example” management style and work ethic.
Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external clients.
Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment.
Ability to work with and influence peers and senior management.
Self-motivated with critical attention to detail, deadlines and reporting.
Participate and support equipment/process FMEAs to understand process and product risks.
Participate and report to a cross-functional team to advance training activities and initiatives.
Work flexible hours for the coverage of training needs.