Production Supervisor, 2nd Shift

Overview

The Production Supervisor leads a sound, efficient, safe, and effective production operation and implements our vision for this business-critical function  role oversees optimal and cost-effective aseptic manufacturing practices in a fast-paced environment through collaboration with stakeholders, production engineers and technicians. The position requires a strong operational, quality, compliance, and technical background and is often hands-on, working closely with the production team to troubleshoot process and equipment challenges.

The supervisor ensures production processes comply with local, state, and federal regulations, including current Good Manufacturing Practices (cGMP).

Second shift is currently defined as 11:00am-7:30pm and will shift to 3:00pm-11:30pm within ~6 months. During training, the 2nd shift production supervisor may occasionally work 1st shift (7:00am-3:30pm). Hours may vary depending on company requirements.

• Organizes and leads production operations and associated activities to drive production target while maintaining quality, cost, and customer service expectations within a safe working environment.
• Manages a team of production technicians.
• Manages production KPIs including labor budget, yield, and OEE, and ensures target production metrics are met.
• Communicates production results and challenges; troubleshoots and implements solutions to issues quickly and efficiently to avoid potential delays.
• Ensures all tasks related to manufacturing operations are performed in accordance with cGMP and SOPs, and ensures batch record requirements are completed in a timely manner.
• Supervises all aspects of production, including assembly, disassembly, cleaning, and storage of manufacturing equipment, cleaning of the cleanroom facility, formulation, filling/finishing, and product shipping operations for the second shift.
• Acts as a subject matter expert on Manufacturing Practices, including aseptic behaviors and practices.
• Implements continuous improvement leveraging Six Sigma, Lean, or Toyota Production System (TPS) approaches.
• Adheres to workplace safety laws, regulations, standards and practices and advances a culture of safety within their team.
• Resolves or escalates problems affecting product quality, safety, and production line performance.
• Operates equipment, performs set-up/change-over/cleanups, assists in preventative maintenance, and troubleshoots equipment to achieve optimum targets.
• Establishes a working environment that fosters participation within and between teams.
• Hires, trains, develops, disciplines, and discharges production technicians.
• Develops, mentors, and supports production technicians in continuous improvement efforts and employee engagement.
• Ensures compliance with Quality Assurance and Quality Control requirements and participates in investigations and corrective/preventive actions (CAPA).
• Maintains records per SOPs and cGMP requirements; generates production batch procedural documentation, manages change assessments, and nonconformance reports.
• Creates, updates, reviews, and maintains production-related SOPs; reviews and approves documents including SOPs, batch records, and material specifications.
• Leads execution of and training for newly transferred or existing products and processes; leads and assists with continuous improvement of production operations and procedural documentation.
• Organizes and leads initial and ongoing training of new and existing personnel.
• Maintains appropriate inventory of production supplies and materials; ensures on-time delivery and quality through accurate work orders, on-time shipping, and correct inventory consumption.
• Other responsibilities as required or assigned by management.

Education
:
Bachelor’s degree with a focus on science or engineering is preferred.

Qualifications
:

• 3+ years of relevant cGMP manufacturing experience with at least one year in a hands-on supervisory role.
• Experience in GMP cleanroom operations, including aseptic processing.
• Strong leadership skills with the ability to motivate staff and foster a culture of operational excellence.
• Experience supporting regulatory inspections and audit readiness.
• Experience with lean manufacturing or Six Sigma.
• Working knowledge of quality management systems.
• Preferred experience in formulation, fill and finish operations, and packaging.
• Ability to multitask, prioritize, and maintain attention to detail.
• Team-oriented with the ability to influence decisions and build relationships.
• Proven ability to build and maintain a high-performing team and lead operational and cultural change initiatives.
• Experience training technical personnel; ability to motivate in a deadline-driven environment.
• Track record of owning quality and efficiency KPIs and driving improvement.
• Demonstrated mentorship, coaching, and development of teammates.
• Strong organizational and time-management skills; ability to prioritize multiple tasks/projects.
• Ability to handle multiple projects of…