Supervisor, Bulk Manufacturing

Why Endo?

We want the best and brightest people at Endo 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.

At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

Job Description Summary

Responsible for daily coordination and execution of working schedules of people and equipment in Bulk Formulation. Responsible for supervising hourly union operators that perform dispensing and formulation 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. 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. Modifies department standard operating procedures, investigates excursions, and executes change controls to support business and quality objectives. Establishes & maintains cooperative cross-functional relationships with peers in Quality, Sterile 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.

Job Description

Job Summary - a concise overview of the job Responsible for operations utilizing union personnel on day shift for compounding of product and sampling/dispensing activities.

Operations produce a variety of drug and biological products including Par branded, development and generic as well as contract customer products while meeting department quality, safety, delivery and productivity objectives.

Ensures the facilities, equipment, supervision, and staff are properly trained to produce aseptically filled pharmaceutical products.

Ensures coordination of activities with all supporting departments.

Establishes objectives for the department and metrics reporting.

Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract.

Responsible for oversight union personnel in Bulk Manufacturing and Drug & Chemical (D&C).

Initiates and/or reviews/approves department standard operating procedures, investigations, and change controls to support business and quality objectives.

Establishes & 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.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Supervisor overseeing Bulk and D&C operations at Rochester, MI manufacturing plant; responsible for 10 union personnel

Key Accountabilities -

Operations

▪ Runs operation to meet or exceed delivery performance objectives for product or projects.

▪ Responsive to changes in daily workflow and schedule; determines needs & redeploys resources and/or overtime to achieve delivery & 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.

▪ Maintains a safe work environment.

Compliance

▪ Understands & adheres to good documentation practices (GDP)

▪ Drives Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure.

▪ Confidently demonstrates knowledge and executes proficiently in at least one QMS area: deviation management and/or change control.

▪ Conducts investigations for root cause, determines corrective action, and impact; writes reports & ensures timely closure.

Approves investigations

• Counsels, trains, & develops union colleagues for efficient performance; creates an a