Supervisor, Inspection and Packaging (Swing)

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.

Job Description Summary

The Supervisor, Packaging is responsible for monitoring all packaging line operations to ensure adherence to all SOPs, cGMPs, OSHA and safety requirements. Schedules packaging line activities and maintains responsibility for departmental staffing. Execute packaging schedule in accordance to packaging plan.

Job Description

The Supervisor, Inspection and Packaging is responsible for daily operations utilizing hourly union operators that inspect and package a variety of drug and biological products, including branded, development, and generic as well as contract customer products while meeting department quality, safety, delivery, and productivity objectives. Directly supports the execution of departmental and site objectives, as well as metrics reporting. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. Responsible for oversight and accountability of hourly colleagues in Inspection and Packaging. Ensures compliance with documentation reviews, training, and change control.   Initiates, and/or reviews and approves department standard operating procedures, investigations, and change controls to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Sterile Operations, Process Development, and Supply Chain to meet plant objectives.

Efficiently directs the daily flow of people, materials, and equipment to ensure an efficient and compliant operational team performs to meet or exceed site standards.

Operations 25%

§  Supervises the operational iPOC center to meet or exceed delivery performance objectives for products or projects

§  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 packaging equipment is working properly

§  Maintains a safe work environment

§  Utilizes critical thinking to identify Continuous Improvement items to enhance workflows and maximize OEE

§  Conducts online and offline MBR review and ERP transactions to support the timely flow of finished product and WIP

§  Review and oversight of serialization systems and the associated tasks to ensure all finished product complies with DSCSA

Compliance 25%

§  Understands and 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 cause, determines corrective action, and impact; writes reports and assures timely closure.   Supports investigations and/or change control plans

§  Counsels, trains, and develops Group Leaders, and union colleagues for efficient performance; creates an atmosphere of team effort and open communication

§  Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes

§  Creates and reviews CMMS work orders to maintain queue

§  Creates, reviews, approves, and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety

§  Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance

§  Follow and comply with company Safety policies and OSHA Regulations

§  Participates in development and maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies.   Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions
 

Supervisory 25%

§  Reports daily production updates at daily Huddle or Tier I/II meetings

§  A