Manufacturing Production Supervisor - Osmotica Pharmaceuticals

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.