GMP Manufacturing Lead

PROMED MOLDED PRODUCTS INC•Plymouth, MN

3d•$32 - $45•Onsite

About The Position

The mission of the GMP Manufacturing Lead is to ensure that production runs smoothly, compliantly, and on schedule across the manufacturing floor. This role serves as the operational backbone of the Technical Operations team, coordinating the people, materials, and systems needed to execute batches right the first time, while maintaining the documentation rigor and investigative discipline that our clients and regulators expect. The position requires strong organizational and scheduling skills, hands-on GMP manufacturing floor experience, and the ability to work across Quality, Materials Management, and Manufacturing to keep production moving without compromising compliance. The GMP Manufacturing Lead supports ProMed’s mission and values by applying and reinforcing the company’s brand, philosophy, systems, policies, and procedures are consistently applied and upheld in all aspects of their work.

Requirements

Working knowledge of cGMP requirements, Good Documentation Practices (GDP), and batch record review.
Hands-on experience with production scheduling and ERP/MRP systems in a regulated manufacturing environment.
Experience supporting or leading deviation investigations and CAPA development.
Strong organizational skills and the ability to manage competing priorities across multiple concurrent batches or programs.
Effective coaching and communication skills to support operator training and floor-level problem solving.
High school diploma or equivalent required
3+ years of experience in pharmaceutical or biotech GMP manufacturing, with prior experience in scheduling, production support, or a lead operator role.
Demonstrated experience with batch record review and Good Documentation Practices.
Experience with ERP/MRP systems for production and material transactions.
Working knowledge of deviation and CAPA processes in a regulated manufacturing environment.

Nice To Haves

Associate's or Bachelor's degree in a technical or life sciences field preferred.

Responsibilities

Develop, maintain, and communicate the GMP production schedule across client programs, balancing equipment availability, staffing, and material readiness.
Coordinate with Planning, Quality, and Materials Management to sequence batches and resolve scheduling conflicts.
Proactively identify and escalate scheduling risks, such as material delays, equipment downtime, or staffing gaps, that could impact on-time production.
Adjust production schedules in response to deviations, equipment issues, or changing client priorities while minimizing disruption.
Support material staging and job/work order setup in the ERP system to ensure batches are ready to run as scheduled.
Verify material availability, lot status, and bill of materials (BOM) accuracy prior to production start.
Coordinate with Supply Chain and Warehouse teams to resolve material shortages or discrepancies identified during job setup.
Maintain accurate ERP records reflecting production status, material consumption, and batch completion.
Ensure operators are trained and qualified on relevant SOPs, batch records, and equipment prior to performing production activities.
Coordinate with Training and Quality functions to track training status and close gaps ahead of scheduled production.
Support on-the-job training and mentoring of operators to reinforce GMP practices and consistent execution on the floor.
Identify recurring training gaps and recommend improvements to training content or delivery.
Perform first-line review of executed batch and packaging records for completeness, accuracy, and compliance with Good Documentation Practices (GDP).
Identify and resolve documentation errors or gaps with operators in real time to prevent downstream delays in Quality review.
Escalate significant discrepancies or data integrity concerns to Quality Assurance promptly.
Support timely closure and release of production records to meet batch disposition timelines.
Initiate deviation reports for manufacturing events and provide accurate, detailed accounts of what occurred on the floor.
Support root cause investigations by gathering data, interviewing operators, and reviewing equipment and batch records.
Partner with Quality Assurance to develop and implement corrective and preventive actions (CAPAs) arising from manufacturing deviations.
Track open deviations and CAPAs affecting the manufacturing floor to ensure timely closure.