Rochester, Michigan, USA
1 day ago
Supervisor - Sanitation

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, Sanitation is responsible for daily coordination and execution of working schedules of people and equipment in Sanitation. Responsible for supervising hourly union operators that conduct environmental sanitation of rooms in support of the production of 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. Reviews sanitation activities performed to ensure the frequency and type of cleanings are performed in accordance to the standard operating procedures. Responsible for daily coordination and execution of working schedules of people and equipment in Preparation Services. Responsible for operations utilizing hourly union operators that clean and sterilize equipment and components for aseptic/sterile operations 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. Supervision of approximately 5 operators is typical across all shifts to ensure communication is seamless across all shifts. Responsible for oversight of Group Leads in department, linen/garbing contract as well as general sanitation needs across the facility. 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 and maintains cooperative cross-functional relationships with peers 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 and Company policies and procedures.

Job Description

Oversees executed sanitation activities by reviewing the sanitation schedule; assures operators performed these activities per the required standard operating procedures

Responsible for sanitation equipment, cleaning chemicals and garb ordering and availability on the floor

Runs operation to meet or exceed delivery performance objectives for product or projects.  Set priorities & 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  & 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.

Performs control checking & reviews GMP records prior to submission to Quality

Maintains a safe work environment.

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

Approves maximo work orders

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 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

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

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

Reviews operational performance; executes improvement opportunities

Counsels, trains, and develops union colleagues for efficient performance; creates an atmosphere of team effort and 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 deliverables; proactively demonstrates the ownership to achieve

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

Supports CMO audits or regulatory agency inspections

Keeps current with industry practices/requirements for environmentally graded operating areas

Education

Required- B.A. /B.S. Degree in Science, Business or related field or significant experience.

Desired - B.A. /B.S. Degree in Packaging Science

Experience

Required – None

Desired – 1- 3 years in a Clean Room Environment, Pharmaceutical Packaging, Operations or a Quality Department

Previous experience in a supervisory role.

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.

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