• Plymouth, MN
    9 days ago

    Job Description

    Team: Operations - Pharma

    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 Material Handler is to ensure that every raw material, component, and finished good entering and residing in our facility is received, sampled, and stored in strict compliance with cGMP requirements. This role serves as the frontline safeguard of material integrity, protecting our clients' products from the moment a shipment arrives through its release to production.

    The position requires disciplined attention to detail, working knowledge of GMP documentation practices, and the ability to coordinate effectively with Quality Assurance and Quality Control to keep materials moving without compromising compliance.

    The Material Handler 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:

    Receiving & Inspection

    On average, this will represent about 35% of your time. In this aspect of your position, we will expect you to:

    • Receive incoming shipments of raw materials, components, and packaging materials, verifying contents against purchase orders, packing slips, and certificates of analysis (CoAs).
    • Perform visual inspection of incoming materials for damage, contamination, correct labeling, and container integrity.
    • Reconcile discrepancies in quantity, condition, or documentation and initiate discrepancy or deviation reports as required.
    • Assign incoming materials a quarantine status pending Quality release.
    • Assist in maintaining traceability and lot genealogy records for regulatory and audit readiness.

    Quality Coordination

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

    • Coordinate with Quality Assurance and Quality Control to track material disposition status, including quarantine, approved, and rejected.
    • Support investigations related to material nonconformances, out-of-specification (OOS) results, or supplier quality issues.
    • Ensure materials are not released to production until appropriate QA approval and documentation are in place.
    • Assist in maintaining traceability and lot genealogy records for regulatory and audit readiness.

    GMP Storage & Inventory Control

    On average, this will represent about 45% of your time. In this aspect of your position, we will expect you to:

    • Store materials in designated warehouse locations according to storage condition requirements (temperature, humidity, light sensitivity) and status segregation.
    • Issue, dispense, and kit released materials to production per work orders.
    • Coordinate and perform material transfers between sites.
    • Monitor and log environmental conditions in storage areas as required.
    • Maintain FIFO/FEFO (first-in-first-out/first-expired-first-out) inventory practices.
    • Perform cycle counts and physical inventory reconciliation.
    • Coordinate shipments of released product.
    • Maintain a clean, organized, and audit-ready warehouse consistent with cGMP and safety standards.
    • Support system improvements for inventory control infrastructure and practices.
    • Operate material handling equipment, such as pallet jacks and forklifts, safely and in compliance with site safety procedures.

    Necessary Expertise and Skills:

    • Working knowledge of cGMP, Good Documentation Practices (GDP), and basic quality systems (deviations, CAPA).
    • Ability to read and interpret SOPs and material specifications.
    • Basic computer proficiency, including ERP/inventory systems and Microsoft Office.
    • Strong attention to detail and organizational skills.
    • Effective communication skills for cross-functional coordination with Quality, Production, and Procurement.

    MINIMUM REQUIREMENTS

    Minimum Qualifications For The Role:

    • High school diploma or equivalent; Associate's degree preferred.
    • 1 to 3 years of experience in a warehouse, distribution, or material handling role, preferably within a pharmaceutical, biotech, or regulated manufacturing environment.
    • Prior cGMP experience strongly preferred.
    • Ability to lift up to 50 lbs and operate powered industrial trucks (certification provided if not already held).

    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.
    • Lifting, carrying, pushing, or pulling materials (varying weights, e.g., up to 25-50 lbs, adjust per actual role)
    • Manual dexterity for handling small components, labels, and documentation
    • Visual acuity to inspect materials for damage, defects, or labeling accuracy
    • Ability to read fine print on labels, certificates of analysis, and documentation
    • Auditory awareness for warehouse safety signals, equipment alarms, or verbal instructions
    • Problem-solving skills to identify and escalate discrepancies or non-conformances
    • Ability to prioritize and multitask in a fast-paced environment without compromising accuracy
    • Comprehension of regulatory/compliance language (cGMP terminology)
    • Hand-eye coordination for equipment operation and precise material placement

    HOW YOUR SUCCESS WILL BE MEASURED

    Determination of how successful you are is a mix of WHAT you achieve, HOW you achieve it, and how you GROW over time.

    Your Key Performance Indicators:

    Within the first 12 months, the Material Handler will be expected to:

    • Demonstrate consistent, error-free receiving, sampling, and documentation practices.
    • Maintain zero material mix-ups or status-labeling errors.
    • Support successful completion of internal and external audits with no material-handling observations.
    • Contribute to on-time release of incoming materials to support production schedules.
    • Build strong working relationships with Quality and Production teams.

    Expected Competencies:

    Regulatory Knowledge

    Working knowledge of cGMP requirements and regulations

    Understanding of GMP documentation practices and recordkeeping standards

    Technical/Operational Skills

    Receiving, sampling, and inspecting incoming raw materials, components, and finished goods

    Proper material storage practices (labeling, segregation, environmental conditions)

    Inventory management and material tracking

    Use of warehouse/inventory management systems (WMS/ERP)

    Basic math and measurement skills for sampling and counting

    Safe operation of material handling equipment (forklifts, pallet jacks, etc.), if applicable

    Attention to Detail

    Disciplined accuracy in documentation and data entry

    Ability to identify discrepancies, damage, or non-conforming materials

    Compliance & Quality Focus

    Ability to maintain material integrity and traceability throughout the receiving-to-release process

    Understanding of chain-of-custody and quarantine/release procedures

    Communication & Collaboration

    Effective coordination with Quality Assurance (QA) and Quality Control (QC) teams

    Clear verbal and written communication skills

    Ability to escalate issues or discrepancies promptly

    Organizational Skills

    Time management to keep materials moving efficiently without compromising compliance

    Prioritization skills in a fast-paced, deadline-driven environment

    Physical Requirements

    Ability to lift, carry, or move materials as needed

    Comfortable working in a warehouse/production environment

    Company Alignment

    Understanding and reinforcement of company policies, procedures, and values

    Professionalism and consistency in representing company brand/philosophy

    Behavioral Competencies

    Reliability and accountability

    Adaptability to changing priorities or material flow

    Team-oriented mindset with a safety-first approach

    ProMed offers a generous benefits package including:

    • 401k with company match
    • Profit Sharing Program
    • Medical Insurance
    • Health Savings Account/Flexible Spending Account
    • Dental Insurance
    • 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.

    1st

    Numbers & Facts

    LocationPlymouth, MN

    Skills

    • Analysis Skillsunmatched
    • Biotech and Pharmaceuticalunmatched
    • Cleanroomunmatched
    • Communication Skillsunmatched
    • Computer Skillsunmatched
    • Corporate Policiesunmatched
    • Cross-Functionalunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Detail Orientedunmatched
    • Discrepancy Reportunmatched
    • Distribution Warehousingunmatched
    • Documentationunmatched
    • ERP (Enterprise Resource Planning)unmatched
    • Environmental Monitoringunmatched
    • Establish Prioritiesunmatched
    • External Auditunmatched
    • FIFOunmatched
    • Forkliftunmatched
    • GMP (Good Manufacturing Practices)unmatched
    • Health Insuranceunmatched
    • Healthcare Softwareunmatched
    • High School Diplomaunmatched
    • Hospitalunmatched
    • Insuranceunmatched
    • Internal Auditunmatched
    • Inventory Control Systemunmatched
    • Inventory Cycle Countsunmatched
    • Inventory Managementunmatched
    • Lift/Move 50 Poundsunmatched
    • Manual Dexterityunmatched
    • Manufacturingunmatched
    • Material Auditunmatched
    • Material Movingunmatched
    • Materials Trackingunmatched
    • Mathematicsunmatched
    • Microsoft Officeunmatched
    • Multitaskingunmatched
    • Neurologyunmatched
    • Order Picking/Packingunmatched
    • Organizational Skillsunmatched
    • Pallet Jackunmatched
    • Performance Metricsunmatched
    • Philosophyunmatched
    • Physical Demandsunmatched
    • Physical Inventoryunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Product Packagingunmatched
    • Production Scheduleunmatched
    • Production Supportunmatched
    • Production Systemsunmatched
    • Purchase Ordersunmatched
    • Purchasing/Procurementunmatched
    • Quality Assuranceunmatched
    • Quality Controlunmatched
    • Receiving Inspectionunmatched
    • Reconciliationunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Release Management/Engineeringunmatched
    • Safety Complianceunmatched
    • Safety Processunmatched
    • Safety Standardsunmatched
    • Sampling Inspectionunmatched
    • Team Playerunmatched
    • Time Managementunmatched
    • Traceabilityunmatched
    • Warehousingunmatched
    • Writing Skillsunmatched

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