Supervisor, Preparation Services Operations

4 weeks ago

Rochester, Michigan, United States Endo International Full time
Job Title: Supervisor, Preparation Services Operations

Endo International is seeking a highly skilled and experienced Supervisor, Preparation Services Operations to join our team. As a key member of our operations team, you will be responsible for overseeing the daily coordination and execution of working schedules of people and equipment in Preparation Services.

Key Responsibilities:
  • Run operations to meet or exceed delivery performance objectives for product or projects.
  • Set priorities and verify availability of resources.
  • Responsible for schedule adherence and 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.
  • Perform control checking and reviews GMP records prior to submission to Quality.
  • Maintain a safe work environment.
  • Compliance with good documentation practices (GDP) and executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures, etc.) to on-time closure.
  • Obtain knowledge and execute assignments in QMS areas: deviation management and/or change control.
  • Conduct investigations for cause, determine corrective action, and impact; write reports and assure timely closure.
  • Initiate and execute change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes.
  • Initiate and Approve maximo work orders for equipment repairs or modifications.
  • Create, review, and conduct operator training programs and assure 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.
  • Participate in development and maintenance of a safe manufacturing environment. Establish methods in compliance with regulatory, plant, and corporate policies. Participate in safety meetings, investigate accidents, and take appropriate corrective action to eliminate hazardous conditions.
  • Reports production updates and schedule changes to team and/or at daily Huddle or SMART meeting.
  • Assure hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provide constructive operator feedback.
  • Assign manpower; initiate documentation of violations and disciplinary action with operators as required.
  • Request equipment and facility repairs, or modifications.
  • Understand and comply with Union Agreement.
  • Keep manager informed of operations; elevate as needed.
  • Reviews operational performance; drives 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 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.
  • Supports Process Development projects through preparation of equipment menus and kit formation.
  • Coordinates residuals sampling requirements with QC resources.
  • Responds to requests of contract customers and ensures their needs and process concerns are conveyed to all colleagues.
Requirements:
  • Education: B.A./B.S. Degree in Science, Business, or related field or significant experience.
  • Desired: B.A./B.S. Degree in Packaging, Science, and/or Management degree.
  • Experience: Required – None. Desired – 1-3 years in Pharmaceutical Packaging, Operation, or Quality Department with increasing levels of responsibility or equivalent.
  • Knowledge: Knowledge of Enterprise Resource Planning tools (JD Edwards); Quality MS (Management Systems), Document MS, Learning MS (Trackwise, Master Control, and ComplianceWire respectively); and MS Office Suite; Kronos, Maximo.
  • Solid understanding of all current state, federal, and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA, and DEA.
Skills and Abilities:
  • Quality: Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
  • Quantity: Meets productivity standards; completes work in a timely manner; strives to increase productivity; works quickly.
  • Safety and Security: Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.
  • Attendance/Punctuality: Is consistently at work and on time; ensures work responsibilities are covered when absent; arrives at meetings and appointments on time.
  • Dependability: Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals.
  • Technical Skills: Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.
  • Interpersonal Skills: Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others' ideas and tries new things.
  • Written Communication: Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs and intended audience; presents numerical data effectively; able to read and interpret written information.
  • Teamwork: Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; able to build morale and group commitments to goals and objectives; supports everyone's efforts to succeed.
  • Analytical: Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs work flows and procedures.
Physical and Work Requirements:
  • Routine entry into a manufacturing environment that requires garbing in and out of environmentally controlled areas up to ISO Grade 5.
  • Stand, Walk, Sit, Talk, and/or Hear.
  • Occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.
  • Specific vision abilities required by this job include close vision.
  • Frequently working near or exposed to moving mechanical parts.
  • The noise level is moderate.
  • Occasional exposure to fumes, airborne particles, toxic, or caustic chemicals.
  • Work environment is a production/manufacturing plant.

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