MANUFACTURING SUPERVISOR
Main Duties and Responsibilities
The Production Supervisor is responsible for leading Production Technician staff with daily activities and training. Provide verbal and written instructions in a clear and concise manner.
Job Responsibilities
- Monitors and supervises the daily operations of the Manufacturing and Packaging production department, ensuring compliance to cGMP’s, written and safety procedures at all times.
- Reviews documentation generated by the Manufacturing and Packaging production department (i.e., batch records, log books, forms, etc.) for completeness and correctness; Executes production schedule.
- Develops and/or revises documentation (i.e., batch records, forms, standard operating procedures, etc.) to maintain compliance with regulatory requirements.
- Troubleshoots production problems, document findings, and implement solutions while providing all information to Management for risk assessment; schedule preventative maintenance activities.
- Trains and evaluates new employees as required.
- Conduct performance appraisals as required.
- Communicate with the incoming/outgoing supervisor and shift personnel to assure continuity and complete information pass-off.
- Develop employees and maintain proper documentation to ensure employee competence.
- Follow and enforce company SOP’s.
- Follow and enforce company guidelines set forth in the Osmotica handbook.
- Assure production employees attend annual cGMP training.
- Perform transactions using electronic inventory system related to manufacturing activities.
- Write and revise standard operating procedures, as required.
- Proven knowledge of company-supported application software (i.e., Microsoft Windows, Word, Excel and Power Point.
- Point out possible difficulties and assure compliance with the production schedule.
- Assure and provide classroom and hands-on training for batch records, SOP’s, and cGMP training for manufacturing.
- Assure that all batch records are reviewed, corrected, and submitted to QA within 48 hours of batch completion.
- Keep current with FDA/cGMP, OSHA, EPA regulations as they relate to the department. Initiate training or proper action as required.
- Review attendance records and take disciplinary action as required.
Requirements
- BS in Science or related field preferred. Relevant work experience in Manufacturing and/or pharmaceutical industry may be considered in lieu of degree
- Previous supervisory experience is preferred.
- Strong mechanical and mathematical aptitude
Core Competencies
- Ability to work 1st, 2nd and 3rd shifts and overtime as required.
- Ability to work weekends and holidays as required.
- Ability to wear respirators, PAPR and other protective equipment
- Ability to perform physical activity (ability to life 40 lbs without assistance)
- Demonstrate the ability to write legibly and communicate clearly by successful completion of a writing sample
- Experience and knowledge of cGMP and compliance issue.