Production Supervisor

Harrow, Inc.•Roxbury Township, NJ

22d•Onsite

About The Position

The Production Supervisor directly leads Operations activities in the Production area and oversees direct reports. This role ensures manufacturing, filling, inspection, packaging, and labeling work is executed accurately, meets high quality standards and applicable cGMP requirements, and is completed on time according to the production schedule. The supervisor is expected to work with a high degree of accountability and customer service to promptly meet client needs. The role provides leadership and direction to the Sterile Production team, supervises a one-shift operation, and spends at least 50% of available time on the production floor. The supervisor must be gown qualified to supervise clean-room production and is responsible for reviewing and approving production batch records. The position also works with Quality, Supply Chain, MS&T, and Maintenance to manage changing priorities and meet production schedules. The Production Supervisor maintains controlled, compliant sterile operations through accurate batch documentation and SOPs, current personnel training, approved documentation templates, properly maintained and calibrated equipment, and high housekeeping standards. The role evaluates production problems, develops and tests solutions, reports findings and recommendations to management, and drives continuous improvement across manufacturing, filling, packaging, and related equipment. Additional duties include writing investigations and CAPAs, maintaining SOPs and manufacturing specifications, monitoring department KPIs, assisting with staffing decisions, providing employee feedback, and supporting the safety program.

Requirements

High school diploma required.
3–5 years of leadership experience in a cGMP-regulated environment.
Experience working in a pharmaceutical, biotechnology, or medical device manufacturing facility.
3–5 years of experience in pharmaceutical or medical device manufacturing.
Ability and willingness to work and participate effectively in a team environment.
Ability and willingness to maintain accurate and factual hard-copy and electronic records.
Attention to detail, safety, quality, and customer requirements.
Ability to communicate effectively verbally and in writing with subordinates, peers, and management.
Ability to read information and apply it to situations involving several details or multistep processes.
High level of personal motivation and initiative.

Nice To Haves

Bachelor's degree preferred.
Experience in a sterile manufacturing environment preferred.

Responsibilities

Provide overall leadership and strategic direction to the Sterile Production team, fostering collaboration, accountability, and a positive, creative team environment aligned with organizational values.
Supervise a one-shift operation and spend at least 50% of available time on the floor to ensure batches meet quality standards, cGMP requirements, and safety guidelines.
Maintain gown qualification to supervise production in the clean room and promptly review and approve production batch records.
Meet the production schedule by distributing workload in collaboration with Quality, Supply Chain, MS&T, and Maintenance.
Maintain controlled and compliant sterile production operations, including accurate batch documentation and SOPs, current personnel training, exact documentation templates, calibrated and maintained equipment, and high housekeeping standards.
Evaluate and resolve production problems by analyzing issues, developing and testing solutions, and preparing summary reports and recommendations for management.
Drive continuous improvement by completing work on time, identifying issues, and improving manufacturing, filling, and packaging processes and equipment procedures.
Write investigations and CAPAs for non-conformances and deviations, and write and maintain SOPs and manufacturing specifications.
Develop and monitor KPIs to improve scrap, non-conformance, batch record errors, and plant efficiencies.
Assist with hiring and disciplining staff as required, provide feedback, and support the company's safety program.
Perform other duties as assigned.