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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

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.

Job Description

• 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

• 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

• 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 & 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

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

• Assures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedback

• Assigns manpower; initiates documentation of violations and disciplinary action with operators as required

• Requests equipment and facility repairs, or modifications

• Understands and complies with Union Agreement

• Keeps manager informed of operations; elevates as needed

• Reviews operational performance; drives improvement opportunities

• Counsels, trains, and develops union colleagues for efficient performance; creates an atmosphere of team effort & open communication

• Consistently communicate, follow and enforce SOP’s and company policies and guidelines set forth in the employee handbook

• Troubleshoots or resolves issues impeding department daily/weekly objectives/deliverables; proactively demonstrates the ownership to achieve

• Interfaces with suppliers of equipment or products and area consultants/experts

• Conducts/supports CMO audits or regulatory agency inspections

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

EEO Statement:

At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.