GMP Materials Management Specialist

Spring Point Project is committed to improving the lives of people with Type 1 diabetes by providing a virtually unlimited supply of medical-grade, high-health pigs to serve as safe islet cell donors to people with diabetes. We envision a world without diabetes, a world where monitoring and daily insulin injections are no longer a part of anyone's life. Position Objective Perform specialized GMP-compliant material management tasks, including tracking, ordering, receipt, inventory/reconciliation, storage and disposition of raw materials, to ensure the schedules and goals of the organization are met by managing shipping and receiving, inventory, and ordering of supplies and materials. Key Responsibilities Oversee the purchasing, receipt, quarantine, storage, and inventory control of raw materials and components, ensuring strict compliance with Good Manufacturing Practices (GMP) and adherence to the Approved Supplier List (ASL) for all procurement activities. Perform precise inventory counts, manage material traceability (lot/batch numbers), maintain strict environmental protocols (GMP/ISO), and ensure accurate documentation in systems. Supports quality control and assurance activities by ensuring inbound and outbound shipments are accurate, complete and adhere to quality management system, customer requirements, and GMP regulatory requirements.

Primary Job Duties Inventory Control, Accuracy & Material Lifecycle Management:

• Manage materials within approved inventory management system
• Perform routine inventory counts, cycle counts, and discrepancy investigations in accordance with SOPs to ensure material availability.
• Receive incoming materials and perform visual inspection for damage and completeness, along with verification against purchase order and accompanying documentation upon receipt.
• Manage the intake, storage, and movement of materials based on QA-approved status, including quarantine and rejected materials.

Logistics, Storage, & Safety Compliance:

• Coordinate receiving, shipping, and storage, including temperature-controlled materials.
• Coordinate the sampling of raw materials in accordance with approved procedures and manage the shipment of samples to external testing organizations.
• Manage the archival of raw material, in process, and finished product retention samples.
• Manage the shipment of finished products to recipients after QA approval, ensuring compliance with GDP and shipping requirements.
• Adhere to hazardous material handling and safety protocols (e.

g., SDS, PPE)

GMP Compliance & Documentation:

• Lead or support the implementation and ongoing maintenance of inventory management systems, including configuration, user support, and process improvements, under Quality Assurance oversight to ensure compliance with GMP, data integrity, and validation requirements.
• Ensure all material handling adheres to

GMP, GDP

(Good Distribution Practices), and SOPs. Maintain strict traceability of materials (lot tracking). Maintain precise records of all materials received, stored, and issued, including lot numbers and expiration dates.

• Participate in the documentation and execution of Quality Management events (such as deviation, change control, corrective and preventive action, etc.

)

Cross-functional Coordination and Vendor Communication:

• Collaborate with quality assurance (QA), manufacturing, quality control (QC), and animal care teams to support production schedules.
• Coordinate with suppliers regarding material specifications, shipping, and quality.

Other Duties:

• Assist with the animal procurement procedures.
• Perform other duties as assigned.

May be directed to perform additional job-related tasks other than those specifically presented in this description.

Physical Demand and Work Environment Work Hazards:

Material Handling Hazards:

Struck-by injuries, falling materials, crushing hazards from falling loads, and injuries from manual handling or mechanical equipment.

Ergonomic Injuries:

Back injuries, strains, and sprains resulting from repetitive motion, lifting, and transferring heavy containers of materials.

Safety Hazards:

Slips, trips, and falls, particularly in warehousing and manufacturing environments.

Hazardous Exposure:

Potential exposure to controllable hazards associated with product manufacturing, including exposure to chemicals and other agents, dust and allergens from animal exposure, and loud noises from cleanroom operations.

Animal Hazard:

May requires minimal animal contact which contains some element of risk associated with it. Risks of bites/scratches, exposure to allergens, dust, chemicals, biological fluids, and loud noises.

Work Conditions and Constraints:

Environment:

Controlled, cleanroom environment with specific, strict safety and contamination protocols.

Restrictions:

Ability to follow specific, often repetitive, procedural movements.

Health Constraints:

Some roles require no skin irritations, open sores, or respiratory infections.

PPE Tolerance:

Ability to work while wearing full PPE (coveralls, gloves, masks) for extended periods.

Physical Execution:

Stamina:

Ability to remain on feet for extended periods.

Standing and Walking:

Standing for prolonged periods are common. The ability to stand, walk, and move around for extended periods throughout a workday.

Bending and Stooping:

Bending, stooping, crouching, kneeling, and reaching above shoulders or below waist.

Reaching:

Using hands and arms to reach for objects at or below shoulder level, and occasionally overhead.

Lifting and Carrying:

Frequently lift/move up to 25 pounds, sometimes up to 50 pounds.

Climbing:

Ascending or descending stairs. Sedentary to

Light Exertion:

Sitting:

Remaining in a seated, stationary position for prolonged periods.

Repetitive Motions:

Performing tasks that involve repetitive movements of the arms, legs, and hands.

Fine Motor Skills:

Dexterity:

Ability to manipulate instruments, equipment, and supplies, and to perform fine motor tasks.

Handling:

Manipulating and handling objects, tools, laboratory instruments, or controls using hands and fingers.

Computer Use:

Operating a computer and other office equipment, including repetitive motions with the wrists, hands, and fingers.

Keyboarding:

Using hands and fingers to operate a computer keyboard and 10-key numeric keypad.

Other Demands:

Vision:

Close vision, depth perception, peripheral vision, and ability to adjust focus. Specific vision abilities, including close visual acuity for reading and analyzing data on a computer screen or via a microscope for extended periods.

Sensory:

Normal talking and hearing.

Communication:

Speaking and hearing to exchange information in person or over the telephone.

Cognitive & Mental Stamina:

Ability to work under pressure and respond calmly to auditory signals and animal behaviors. Make rapid, sound decisions in urgent situations. Handling high-stress, emotionally challenging cases.

Education Essential:

High School Diploma or GED.

Desirable:

Degree in Biology, Chemistry, Microbiology, Biochemistry, or other related field preferred. Experience 1-3 years in inventory control, ideally in pharmaceutical, medical device, or similar GMP manufacturing environments. Prior experience working in FDA-regulated environments preferred. Prior experience working in GMP-compliant facilities. Minimum Qualifications (Knowledge, Skills, and Abilities)

Computer Skills:

• Proficiency with Microsoft 365 (Word, PowerPoint, Outlook, SharePoint, OneNote, Teams, Excel, Outlook, etc.)
• Proficiency with Adobe Acrobat
• Experience with CRM, ERP, and inventory management platforms (e.g. SAP, Salesforce, InstantGMP)
• Experience with electronic Quality Management Systems (or willingness to learn)

Technical Skills:

• Working knowledge of GMP, SOPs, contamination control, and material traceability principles.
• Ability to perform and verify veterinary medication dosing (or willingness to learn)

Organizational and Time Management Skills:

• Must have meticulous attention to detail, excellent documentation practices, and strong organizational skills.
• Must be able to work independently with minimal supervision while following strict procedures.
• Must have the ability to work in a cross-functional team environment.
• Must be self-motivated with ability to handle, organize, and prioritize multiple tasks to meet deadlines.

Communication Skills:

• Must have strong communication skills both verbal and written.
• Ability to effectively build and maintain interdepartmental coordination, communication, and relationships.
• Ability to work in a team and follow strict protocols.
• Must have the ability to work in fast-paced, effectively under pressure, and deadline-oriented environment.

Additional Requirements:

Availability:

Must be able to work a flexible schedule including occasional odd-hour, long days, and occasional weekend shifts availability.

Travel:

Must be able to occasionally travel via personal vehicle to delivery locations during the workday (typical destinations are Oakdale MN, Stillwater MN, Roseville MN. Mileage is reimbursed)

Health Assessment:

Due to extreme high herd health, the position is contingent upon meeting strict biosecurity (primarily personal and close contact's swine contact/withdrawal time), background, and pre-employment health and annual health screening requirements. Must pass pre-employment health screening and annual health screening.

Outside Swine Contact:

Cannot reside on or near a swine farm. Cannot be in daily contact (or any individual within the household) with swine outside of the Spring Point Project animal facility.

Pay:

$20.00 - $30.00 per hour Expected hours: 40.0 per week Application Question(s): How many years of GMP experience do you have?

Experience:

Inventory control: 1 year (Required) Ability to

Commute:

New Richmond, WI 54017 (Required)

Work Location:

In person