Supvervisor, Sterile Filling

Overview

Supvervisor, Sterile Filling (Afternoons) – Endo

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Why Endo? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary 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

• 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

Operational and Compliance responsibilities are further defined in the remaining sections of the job description.

Compliance

• Understands and adheres to good documentation practices (GDP)
• Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure
• Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control
• Conducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closure
• Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes
• Initiates and approves Maximo work orders for equipment repairs or modifications
• Creates, reviews and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety
• Ensure proper documentation to maintain compliance; supports classroom and hands-on training for batch records, SOPs, and cGMPs
• Follow and comply with company Safety policies and OSHA Regulations
• Participates in development & maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies; participates in safety meetings, investigates accidents, and takes corrective action

Supervisory

• Reports production updates and schedule changes to team and/or at daily Huddle or SMART…