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 cGMPs, 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 SOPs.
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, SOPs, 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.