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Supervisor - Bulk Manufacturing - Rochester, United States - Jhppharma
3 weeks ago
Description
Supervisor– Bulk Manufacturing
(R-SBMN)
Description:
Responsible for supervision of bulk solution processing in the Bulk Manufacturing Operation and/or dispensing operations of API and excipient materials in the Drug and Chemical area.
This responsibility includes the assigning of processors to individual projects to support the production schedule, coordination of assigned manufacturing and/or dispensing operations to support business objectives, cGMP compliance/ regulatory requirements, and provide for training, meeting established safety standards, achievement of departmental goals, and security of colleagues, .
This responsibility also includes batch card review and submission to QA for review and release to support production goals and delivery objectives.
In partnership with the site leaders sponsors a quality and compliance driven site culture which embraces RFT (right first time) and CI (continuous improvement) outcomes.
Essential Functions / Key Results Areas:Responsible for the direct supervision of department union colleagues. Provides training and support to all department colleagues. Supports colleague compliance with all procedures, current Good Manufacturing Practice regulations and safety rules and contract customer obligations.
Participates in the department training programs and assures that all colleagues receive proper orientation and training.
Responsible for training colleagues, advising them of any changes, and assures that current SOP's and Job Aids are available at the workstations.
Initiates documentation of violations and disciplinary action as required or directed.Participates in meeting, programs and other activities designed to have a positive effect on employees, company, and department objectives and responsibilities.
Conducts monthly safety meetings, schedules required safety training and monitoring (e.g. respiratory, power truck, hearing) and provides and enforces used of required personal protective equipmentSupports Pharm Tech Services projects. Responds to requests of contract customers and ensures their needs and process concerns are conveyed to all colleagues.
Verifies availability of manufacturing rooms, materials, batch cards, etc. Performs control checking and documentation of process operations and equipment. Reviews batch cards for submission to QA all batch cards and supporting records. Verifies all established procedures are being followed.
Prepares a variety of reports/audits including production, safety, housekeeping, etc., and submits on a timely basis.
Keeps Shift Manager/Director informed of all operation.
Required Skills:
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.
:
Experience in a sterile manufacturing facility, knowledge of sterilization theory, knowledge of equipment, familiarity with manufacturing processes, mechanical aptitude (skilled trades background considered), knowledge of cGMPs, knowledge of OSHA regulations, and experience in a union environment.
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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.#J-18808-Ljbffr
