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.
Scope of Authority
Supervisor of Sterile Filling operations at Rochester, MI manufacturing plant; personnel across one shift
Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice
Significant Equipment includes: Washers, Depyrogenation Tunnels, Vial/Syringe/Bottle Fillers, Cappers, Lyophilizers, and Terminal Sterilizers
Key Accountabilities
- 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
Compliance
- 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
Supervisory
- 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
Leadership
- 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
Qualifications
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 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 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
- Personnel from outside the pharmaceutical industry or a directly related industry, i.e., medical devices, food, etc., can be considered after critical assessment of their industry related knowledge. Must be able to gain knowledge and expertise in aseptic processing
Physical & 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