Sterile Filling Supervisor

9 hours ago

Rochester, Michigan, United States Endo International Full time
Job Summary

The Supervisor, Sterile Filling is responsible for overseeing the daily operations of the Sterile Filling department, ensuring that all production schedules are met, and that quality and safety standards are maintained.

Key Responsibilities
  • Supervise hourly union operators in the execution of daily work, ensuring compliance with validated parameters and standard operating procedures.
  • Develop and manage daily/weekly department work schedules, set priorities, and verify availability of resources.
  • Responsible for schedule adherence, participates in scheduling meetings to increase resource utilization.
  • Responsive to changes in daily workflow and schedule, determines needs, and redeploy resources and/or overtime to achieve delivery and customer service commitments.
  • Ensure all equipment is working properly and maintain a safe work environment.
  • Reviews batch records and supporting records prior to submission to Quality.
  • Maintains a safe work environment and completes in-process, set up checks, and verification in alignment with Standard Operating Procedures.
  • Understands and adheres to good documentation practices (GDP) and executes Quality Management System assignments to on-time closure.
  • 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.
  • 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.
  • Follows and complies 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.
  • 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 communicates, follows, and enforces 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 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.

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