Position Summary

The Production Supervisor directly leads the Operations activities in the Production area and oversees direct reports. The Production Supervisor ensures manufacturing, filling, inspection, packaging, and labeling jobs are executed accurately with the highest quality, meet applicable cGMP requirements, and are completed on time per the production schedule. The Production Supervisor works with the highest degree of accountability and customer service to promptly ensure client needs are met.

Core Responsibilities

• Provide overall leadership and strategic direction to the Sterile Production team, aligned with the organization's core values, fostering collaboration, accountability, and a positive, creative team environment.
• Supervise a one-shift operation, spending at least 50% of available time on the floor with employees to ensure all batches meet the highest quality, exceed cGMP requirements, and follow all safety guidelines.
• Be gown qualified to supervise production in the clean room, and review and approve production batch records promptly.
• Ensure the production schedule is met by distributing workload against changing priorities in collaboration with the Quality, Supply Chain, MS&T, and Maintenance departments.
• Ensure sterile production operations are controlled and compliant - maintaining accurate batch documentation and SOPs, current personnel training, exact documentation templates, well-maintained and calibrated equipment, and high housekeeping standards.
• Evaluate and solve production problems by analyzing the issue, developing and testing solutions, and preparing summary reports and recommendations for management.
• Drive continuous improvement by completing work on time, identifying issues, and improving processes and procedures for manufacturing, filling, and packaging equipment.
• Write investigations and CAPAs for non-conformances and deviations, and write and maintain SOPs and manufacturing specifications.
• Develop and monitor KPIs to improve department metrics, including 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.
• Other duties as assigned.

Qualifications & Requirements

• High School diploma required; Bachelor's degree preferred.
• Must have 3-5 years of leadership experience in a cGMP-regulated environment and have worked in a pharmaceutical, biotechnology, or medical device manufacturing facility.
• Minimum of 3-5 years of experience in pharmaceutical or medical device manufacturing, preferably in a sterile environment.
• 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 to subordinates, peers, and management.
• Ability to read information and apply what is described to situations that contain several details or processes involving several steps.
• Demonstrate a high level of personal motivation and initiative.

Position Type

• On-Site