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JHP Pharmaceuticals, LLC
Manager/Packaging and Inspection
Rochester, MI 48306 United States
Regulatory Affairs Specialist
JHP Pharmaceuticals, located in Rochester, Michigan, is an integrated specialty healthcare company that specializes in sterile injectable products. JHP manufactures and sells brand aseptic injectable pharmaceuticals in hospital and clinical settings and provides contract manufacturing services for global pharmaceutical companies. JHP'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.
MANAGER / PACKAGING AND INSPECTION
Responsible for overall coordination and working schedule for two shifts in Packaging. Provides leadership to all Packaging supervisors. Interacts with Packaging Dispatcher to set productive daily/weekly schedule reducing line changeovers while meeting weekly plant delivery schedule. Provide back-up for the department Director. Responsible for visual/Eisai inspection and packaging of a variety of biological, drug, and contract customer products while meeting department quality, safety, delivery and productivity objectives. Assure adequate maintenance of department machinery and miscellaneous supplies. Assures compliance with cGMP’s, company procedures, policies and practices, including labor agreement with bargaining unit colleagues. Coordinates monthly safety reports performed by supervisors. Revises SOP’s, batch records, and Packaging documentation. Interacts with Quality Assurance, Sterile Filling, and Materials Management to meet plant objectives.
The essential functions of the position include, but are not limited to:
• Assures colleagues compliance with all procedures, cGMP’s regulations, safety, and contract obligations. Reviews documentation produced by supervisors for violations of company policy by hourly colleagues and recommends disciplinary actions.
• Sets priorities to meet cycle and testing times. Ensures timely delivery of product to meet schedules
• Initiates changes to batch records, SOP’s, job aids, safety practices and Packaging documentation.
• Counsels, trains and develops supervisors for more efficient performance in their line assignments.
• 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 actions to eliminate hazardous conditions.
• Serves as a backup to supervisors to cover floor operations as needed.
• Maintains inventory of production supplies (tools, tape, debossing characters, etc.) assuring adequate supply is available.
• Demonstrates a thorough knowledge of all procedures relating to the operations in inspection and packaging including product/component reconciliation and documentation methods for Packaging forms and batch records.
• Assuring packaging and label imprinting operations conform to quality specifications and to use reasonable judgment in the absence of a quality specification.
• Assures new supervisors receive adequate training to perform their work assignments in a manner consistent with department quality specifications and department procedures.
• Responsible for initiating changes to SOP’s, job aids, batch records, and Packaging documentation.
• Collaborates with Packaging Dispatcher to maintain efficient product flow, colleague placement, and production priorities.
• Participates in meetings, seminars, programs, and other activities designed to have a positive effect on colleagues, operations, and company objectives. Investigates better methods for inspection and packaging.
• Reports productionstandards are accurate and complete. Investigates low labor performances per batch and makes strides to increase efficiencies in future batches.
• Responds to special assignments/projects by Packaging Director and other department’s special requests.
• Assure equipment and workforce comply with plant safety procedures and practices by providing adequate training and reinforcement to work force.
• Continually monitor machinery and housekeeping to assure a safe working environment.
• Support plant efforts to assure environmental safety through proper disposal of all department waste and alerting designated colleagues of any product spills for proper clean up.
• Assures timely product delivery which meets the department manufacturing cycle time by maintaining an adequate inventory of department tools, tooling and supply items.
• Assures timely turnaround of batch records.
• Schedules routine and emergency maintenance to maintain department equipment.
• Assure department cost and productivity objectives are met by redirecting hourly colleagues, while recognizing contractual constraints to achieve maximum labor productivity.
• Participates in the development of production plans, capacities, and colleague scheduling to meet forecast needs.
• Establishes short-term goals, monitors results, and makes timely adjustments to achieve planned goals.
• Collaborates with Packaging Supervisors on union grievances to effectively maintain the company’s position with regards to the collective bargaining agreement.
Education, training, experience:
EDUCATION AND EXPERIENCE:
Required – B.S./B.A.in Science, Business or related, B.S. /B.A. in Packaging Science preferred.
Required - Minimum of 5 years’ experience in the pharmaceutical industry with emphasis on having held previous supervisory positions.
Ten years supervisory experience with experience in material planning and employee relations strongly preferred.
Knowledge of industry standard practices is very important. Good communication and leadership skills are required.
Desired – post graduate business, management or science education.
Desired – exposure to other Pharmaceutical operations.
Must have parenteral inspection experience.
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