Sterile Filling Department (R-SFSP)
Sterile Filling Supervisor – Sterile Filling Department (R-SFSP)
Location: Rochester, Michigan
Description:
Responsible for supervision of one or more filling lines in the Sterile Filling Manufacturing Operation. This responsibility includes the overall planning, direction, coordination of assigned section operations which will result in the timely, effective, economical manufacturing and shipping of quality products in accordance with approved production budgets, quality control procedures, safety standards, cGMP and other regulatory requirements. In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.
Essential Functions:
The essential functions of the position include, but are not limited to:
- Participates in the design of department training programs and assures that all colleagues receive proper orientation and training.
- Maintains department SOP system. Initiates revisions and updates as required. Responsible for training colleagues, advising them of any changes, and assures that current SOP’s and Job Aids are available at the workstations.
- Participates in the development and maintenance of adequate sanitation programs to meet colleagues and product safety requirements and Current Good Manufacturing Practices (cGMP). Participates in an effective audit program to assure safe and sanitary conditions.
- Must be able to operate any and all equipment in the department for the purposed of training colleagues and checking of operation.
- Participates in meeting, seminars, programs and other activities designed to have a positive effect on employees, company, and department objectives and responsibilities.
- Collaborates with peers and all support groups to obtain maximum quality and efficiency of Sterile Filling Manufacturing.
- Coordinates and performs special requests for service from Manufacturing Quality Control and Pharmtech Services over and above normal production operations. Responds to requests of contract customers and ensures their needs and process concerns are conveyed to all colleagues.
- 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 equipment.
- Orders supplies and components, assigns colleagues, monitors operations and equipment and assures timely documentation and paperwork flow.
- Checks/verifies incoming materials, batch cards, operating supplies, etc.
- Performs control checking and documentation of process operations and equipment.
- Supervises all operations of the assigned Sterile Filling Lines.
- Reviews/checks or approves all batch cards and supporting records.
- Verifies all established procedures are being followed.
- Prepares a variety of reports including production, safety, process deviations, etc. and submits on a timely basis.
- Communicates any schedule, equipment, operational information required both inside and outside the department.
- Responds to all alarms and takes appropriate corrective action.
- Keeps Shift Manager/Director informed of all operations.
- Establishes and Maintains Effective cross functional relationships.
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.
Desired:
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.
If you possess the required background and are interested in being a member of this growing company, submit your resume and cover letter by mail or apply online:
By Mail
MCP Pharmaceuticals LLC HR Department, Job Code SAS
870 Parkdale Road
Rochester, Michigan 48307
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