Production Supervisor (R-PSR) Packaging
Location: Rochester, Michigan
MCP is currently seeking dynamic individuals to fill our Supervisor position. Responsible for daily coordination and working schedule for their assigned shift in Packaging. Responsible for supervising colleagues in inspection (visual and Eisai) and packaging of a variety of drug and biological products both MCP and contract customer products while meeting department quality, safety, delivery and productivity objectives.
1.) Assures adequate maintenance of department machinery. Assures compliance with GMP’s, company procedures/job aids, and union contract. 2.) Conducts monthly safety checks.Modifies department standard operating procedures. 3.) Interacts with Manufacturing Quality Assurance (MQA), Sterile Filling, Pharmaceutical Technology, Material Management and laboratories to meet plant objectives. 4.) Performs batch record card closeouts.
5.) RFT (right first time) and CI (continuous improvement) expectations.
Essential Job Functions :
- Implements daily department work schedules. Ensures timely delivery of product to meet schedules.
- Assures colleagues compliance with all procedures, GMP regulations, safety, and contract obligations. Initiates documentation of violations and disciplinary action as required. Reports and initiates production schedule changes, requests equipment and facility repairs, or modifications. Initiates changes to batch cards, packaging work orders, standard operating procedures (SOP), job aids, safety practices, and provides appropriate training for all union colleagues.
- Counsels, trains, and develops union colleagues for more efficient performance in their assignment and creates an atmosphere of team effort and open communication.
- Participates in the development and maintenance of a safe manufacturing environment by establishing methods in compliance with regulatory, plant, and corporate policies. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions.
- Aids in Cross Functional Investigations when needed. Investigates deviations from batch card or packaging work orders. Required: A BS/BA in one of the life sciences, pharmacy, packaging engineering, or other discipline related to the area supervised and two years of experience in a manufacturing, laboratory, or other related environment, OR, an equivalent combination of education and experience.
A BS/BA in one of the life sciences, chemistry, engineering, or other discipline related to the area supervised and two years of experience in a manufacturing, laboratory, or other related field with strong preference to pharmaceuticals and cGMP environment.
Experience in a sterile manufacturing facility, knowledge of sterilization theory, knowledge of equipment, familiarity with aseptic manufacturing processes, mechanical aptitude, knowledge of cGMPs, lyophillization experience, OSHA regulations. Working in a union environment
If you possess the required background and are interested in being a member of the team, submit your resume and a cover letter on the online application
About MCP Pharmaceuticals, LLC:
MCP Pharmaceuticals is an integrated specialty healthcare company that specializes in sterile injectable products. MCP manufactures and sells brand aseptic injectable pharmaceuticals in hospital and clinical settings and provides contract manufacturing services for global pharmaceutical companies. MCP’s own product portfolio includes leading diagnostic, women’s health and anesthesia products.
All products have a long track record of “gold standard” service and are at or near the front line of treatment in their therapeutic indications. Contract manufactured products include some of the leading global biologic products which involve liquid, lyophilized and suspension presentations.
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