Compliance Specialist – Manufacturing (R-CSMF)
Compliance Specialist – Manufacturing (R-CSMF)
Department: Sterile Filling
Location: Rochester, Michigan
Description: Responsible for facilitating and monitoring compliance efforts and completions in the Sterile Manufacturing Operations. This position will work across all four departments in Sterile Manufacturing (Sterile Filling, Bulk D&C, Prep Services and Sanitation). Specific areas of focus in Sterile Manufacturing will be the elements contained in Trackwise (deviations, change controls, planned process modifications, etc.), training and standard operating procedures.
This position will both utilize existing systems and create new methods to report compliance status information for Sterile Manufacturing. These new methods developed by this position will become efficient tools which can be transferred to and used by supervisory and managerial colleagues. In partnership with the site leaders this position will support a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.
- Develops strong site Trackwise user skills. These skills to be used both for colleague training as well as execution of Trackwise items.
- Develop and cultivate strong relationships with relevant QA colleagues to facilitate flow of timely Trackwise information to/from Sterile Manufacturing.
- Facilitates, participates in and/or delivers relevant departmental training.
- Participates in the design of department training programs and works with departmental supervision to assure all colleagues receive proper orientation and training.
- Provide training exception reporting to identify gaps and facilitate closure.
- Partner with Compliance department to assure Sterile Manufacturing training efforts are aligned with Site and Corporate expectations.
- Supports/facilitates department SOP system. Recommends/initiates revisions and updates as required. Shares in facilitating of training colleagues with departmental supervision.
- 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 support groups to obtain maximum quality and efficiency of Sterile Manufacturing.
- Prepares a variety of reports including compliance, training, standard operating procedures, etc. and submits on a timely basis.
- Keeps Sterile Manufacturing Director informed of all operations.
- Establishes and Maintains Effective cross functional relationships.
Required Education / Experience: A BS/BA in one of the life sciences, pharmacy, packaging engineering, or other discipline related to the work area and two years of experience in a manufacturing, laboratory, or other related environment, OR, an equivalent combination of education and experience.
Desired Education / Experience: Experience in a sterile manufacturing facility, knowledge of equipment, knowledge of statistics, familiarity with manufacturing processes, mechanical aptitude, knowledge of cGMPs.
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
Apply Online
To apply for this position, please Apply Online
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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