Supervisor, Production Operations
About The Position
The Supervisor, Production Operations supervises aseptic filling and sterile subassembly operations and union operators. The role is responsible for ensuring that product filling processes are performed in compliance with current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs). The supervisor directs daily production work, supports safe and compliant operations, reviews batch records, investigates deviations, and coordinates staffing, training, materials, equipment, testing, and production schedules. The position also contributes to SOP updates, labor standards, departmental budgeting, and special projects. Regular onsite attendance is required; the job cannot be performed remotely or by telecommuting.
Requirements
- Bachelor's degree in Biology, Chemistry, Computer Science, or another technology or life science field.
- At least two years of prior work experience.
- Effective written and oral communication skills, including excellent English writing skills and the ability to coach and guide others.
- Computer literacy, including Microsoft applications and Trackwise.
- Reading comprehension and writing proficiency sufficient to meet role or test requirements.
- Ability to communicate effectively within a diverse group and achieve desired outcomes.
- Problem-solving and decision-making skills and experience applying process-improvement tools.
- Ability to stand upright for several consecutive hours, absent medical restrictions that prevent completion of required duties.
- Ability to bend, twist, lift items up to 35 pounds, stand, and frequently walk between production areas.
- Ability to work around moving machines and temperature changes, wear required personal protective equipment, and be gown qualified.
- Willingness to work beyond a regular workday, which may include weekends and holidays.
- Must be a U.S. citizen or national, lawful permanent resident, refugee, or asylee, as specified in the posting.
Nice To Haves
- Pharmaceutical industry background.
- Prior experience in a union shop setting.
- Manufacturing and supervision background.
Responsibilities
- Instruct filling and subassembly operators in their daily duties and ensure work is timely and conforms to cGMP requirements.
- Supervise operations for compliance with safety requirements and promptly address safety events or concerns with Environmental, Health and Safety personnel.
- Perform required GMP audits of the aseptic processing area, investigate process deviations, and review area batch records daily for accuracy and compliance with SOPs and aseptic processing requirements.
- Create or revise departmental SOPs as needed.
- Report significant shift activities to the Manager/TL, perform root cause analysis, and define effective corrective and preventive actions.
- Coordinate staffing activities, including vacation and sick-time coverage; address personnel issues, train new operators, and conduct operator reviews.
- Maintain inventory of materials and sterile items used in the aseptic processing area and maintain and improve labor standards.
- Assist with developing and maintaining the annual department overhead budget and order area supplies.
- Schedule shifts to maintain hands-on operator support and fill in for other supervisors as needed.
- Coordinate with Manufacturing Resource Coordinators on batch records and SOPs; Tech Services on equipment maintenance and repairs; the QC Lab on testing; Materials and Planning on filling schedules and material orders; the Manager/TL on daily activities; and MQA on quality issues and concerns.
- Assist the Production Manager with special projects and perform other related duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
