Supervisor, Prep Services - 3rd Shift
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. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. 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. Initiates, and/or reviews department standard operating procedures to support business and quality objectives. Establishes & 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.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Supervisor of Preparation Services operations at Rochester, MI manufacturing plant; personnel across one shift. Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice.
Significant Equipment includes: Sterilizers, Isolators, Washers, etc.
ROLE AND RESPONSIBILITIES:
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
§ 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 & 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 & assures timely closure.
§ Initiates & executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes.
§ Initiates & Approves maximo work orders for equipment repairs or modifications
§ Creates, reviews and conducts operator training programs & 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 & 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 & complies with Union Agreement.
§ Keeps manager informed of operations; elevates as needed
§ Reviews operational performance; drives improvement opportunities.
§ Counsels, trains, & 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.
§ 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.
Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled