GMP Manufacturing Lead

PROMED MOLDED PRODUCTS INC; Plymouth (MN); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

401k with company match

Profit Sharing Program

Medical Insurance

Health Savings Account / Flexible...

Vision Insurance

Life Insurance

Paid Family Medical Leave

Long‑Term Disability Insurance

Hospital Indemnity

Critical Illness

Accident Insurance

Identity Theft Protection

Pet Insurance

Job summary

Promed Molded Products Inc. is seeking a GMP Manufacturing Lead to ensure smooth, compliant production scheduling and disciplined documentation on the manufacturing floor in Plymouth, Minnesota.

The role coordinates the people, materials, and systems to execute batches right the first time, working cross-functionally with Quality, Materials, and Manufacturing to maintain compliance. The candidate will manage GMP scheduling, ERP/MRP material setup, operator training, and production record review,

Qualifications

• High school diploma or equivalent; technical degree preferred.
• 3+ years in pharma/biotech GMP manufacturing with scheduling or lead operator experience.
• Experience with batch records, GDP, and ERP/MRP systems; CAPA/deviation exposure.

Responsibilities

• GMP Production Scheduling across client programs and ensure on-time batches.
• Material setup in ERP and ensure BOM accuracy.
• Operator training and qualification on SOPs and batch records.
• Review batch and packaging records for GDP compliance.
• Initiate deviation reports and support CAPA investigations.
• Coordinate with Quality, Planning, and Materials to resolve issues.

Skills

GMP manufacturing

Production scheduling

Batch record review

GDP

CAPA investigations

ERP/MRP systems

Coaching

Communication

Attention to detail

Education

High school diploma or equivalent

Associate's or Bachelor's degree (technical or life sciences)

Tools

ERP/MRP systems

Job description

As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

Working as one to help many.

WHY THIS ROLE MATTERS

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.

WHAT YOU’LL ACHIEVE

While the ways that you fulfill these responsibilities will likely evolve, your core responsibilities are:

GMP Production Scheduling

On average, this will represent about 25% of your time. In this aspect of your position, we will expect you to:

• 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 escalation 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.

Material & Job Setup in ERP

On average, this will represent about 20% of your time. In this aspect of your position, we will expect you to:

• 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.

Operator Training & Readiness

On average, this will represent about 15% of your time. In this aspect of your position, we will expect you to:

• 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‑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.

Production Record Review

On average, this will represent about 20% of your time. In this aspect of your position, we will expect you to:

• 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.

On average, this will represent about 20% of your time. In this aspect of your position, we will expect you to:

• 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.

Necessary Expertise and Skills:

• 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.

MINIMUM REQUIREMENTS

Minimum Qualifications For The Role:

• High school diploma or equivalent required; Associate's or Bachelor's degree in a technical or life sciences field preferred.
• 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.

Physical, Sensory, Cognitive & Neurological Demands:

• Requires the ability to safely perform the physical movements necessary to carry out the essential functions of the role, including sitting, standing, walking, bending, reaching, lifting, pushing, pulling, and repetitive movements throughout the workday.
• Occasional lifting of up to 25–50 lbs (materials, totes, supplies)
• Ability to wear required PPE/gowning for extended periods (gloves, gowns, masks, hairnets)
• Manual dexterity for equipment operation, documentation, and material handling
• Visual acuity to read batch records, labels, and fine print, and to detect defects or deviations
• Hearing sufficient to communicate on the floor and respond to equipment alarms
• Ability to work in environments with varying temperature, noise, and lighting conditions
• Strong attention to detail, multitasking, and analytical problem-solving to accurately review documentation, manage multiple concurrent batches, interpret SOPs and regulatory requirements, and investigate deviations through root cause analysis
• Sustained concentration and focus during repetitive documentation and review tasks
• Coordination between visual, cognitive, and motor skills for equipment operation and floor tasks

ProMed offers a generous benefits package including:

• 401k with company match
• Profit Sharing Program
• Medical Insurance
• Health Savings Account/Flexible Spending Account
• Vision Insurance
• Life Insurance
• Paid Family Medical Leave and Long‑Term Disability Insurance
• Hospital Indemnity, Critical Illness, Accident, and Identity Theft Protection
• Pet Insurance

ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.