Supervisor, Sterile Filling (Midnight Shift)

Supervisor, Sterile Filling

The Supervisor, Sterile Filling is responsible for daily coordination and execution of working schedules of people and equipment in Sterile Filling. Responsible for supervising hourly union operators that conduct primary filling, lyophilization and / or terminal sterilization of a variety of drug and biological products, including Par branded, development & generic as well as contract customer products while meeting department quality, safety, delivery and productivity objectives. Responsible for direct supervision of one or more aseptic filling lines. Typically this will involve 3 to 6 operators per line. Supervisors are highly knowledgeable in cGMPs and good aseptic practices; must be skillful at communicating, teaching, and inspiring colleagues to a high level of performance. Responsibility requires a high level of documentation, investigative writing, production planning and labor utilization skills. Reviews and releases batch record documentation; completes yield transactions or component returns. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. Initiates, and / or reviews department standard operating procedures to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Process Development, and Supply Chain to meet plant objectives. 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.

Scope of Authority

Supervisor of Sterile Filling operations at Rochester, MI manufacturing plant; personnel across one shift

Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice

Significant Equipment includes : Washers, Depyrogenation Tunnels, Vial / Syringe / Bottle Fillers, Cappers, Lyophilizers, and Terminal Sterilizers

Key Accountabilities

Operations

• Oversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating procedures
• Develops daily / weekly department work schedules, set priorities and verifies availability of resources
• Responsible for schedule adherence; participates in scheduling meetings with the objectives of increased resource utilization
• Responsive to changes in daily workflow and schedule; determines needs and redeploys resources and / or overtime to achieve delivery and customer service commitments; adapts to ebb / flow of production process including changes due to unplanned maintenance or events requiring investigation
• Ensure all equipment is working properly
• Reviews batch records and supporting records prior to submission to Quality
• Maintains a safe work environment
• Completes in-process, set up checks and verification in alignment with Standard Operating Procedures

Compliance

Supervisory

Leadership

Qualifications

Education & Experience

Education

Experience

Knowledge

Skills & Abilities

To perform the job successfully, an individual should demonstrate the following competencies :