Overview
Position Summary
The Material Management and Operations Coordinator is responsible for managing GMP and R&D materials, coordinating QC samples, and maintaining equipment calibration and preventive-maintenance schedules. This position ensures materials, samples, and equipment records are accurate, traceable, properly controlled, and compliant with applicable GMP procedures.
Key Responsibilities
GMP Material Management
- Receive, inspect, label, log, quarantine, store, and issue GMP raw materials, intermediates, packaging components, and consumables.
- Verify material identity, quantity, condition, lot number, expiration or retest date, and supporting documentation.
- Maintain accurate material status, location, inventory, and transaction records in approved systems.
- Coordinate material sampling, testing, release, rejection, return, and disposal with QA and QC.
- Ensure materials are stored under approved temperature, humidity, segregation, and security conditions.
- Apply FEFO/FIFO principles and monitor material expiration and retest dates.
- Support inventory reconciliation, cycle counts, and investigation of discrepancies.
- Maintain traceability and documentation for all GMP material movements.
R&D Material Management
- Receive, organize, track, store, and issue R&D chemicals, reagents, reference standards, solvents, and laboratory supplies.
- Maintain inventories, storage locations, quantities, expiration dates, and safety documentation.
- Coordinate purchasing and replenishment based on project and laboratory needs.
- Ensure proper labeling, segregation, and storage of hazardous or temperature-sensitive materials.
- Support disposal of expired, unused, or hazardous materials according to approved procedures.
QC Sample Management
- Receive, log, and distribute QC GMP samples and reference standards.
- Maintain sample records, including the sample receipt logging, storage locations, inventory, distribution, and destruction.
- Ensure sample identification, quantity, condition, and documentation are complete.
- Maintain chain-of-custody records and coordinate sample transfers to analysts or external laboratories.
- Support sample reconciliation, retention, archival, shipment, return, and disposal.
- Report any damaged samples, discrepancies, or storage excursions promptly.
Equipment Calibration and Maintenance Scheduling
- Maintain the master calibration and preventive-maintenance schedule for laboratory, production, warehouse, and facility equipment.
- Track calibration, qualification, certification, and maintenance due dates.
- Coordinate service activities with equipment owners, vendors, QA, QC, and Operations.
- Issue reminders and follow up to ensure activities are completed before due dates.
- Maintain calibration certificates, service reports, equipment files, and status labels.
- Notify QA and equipment owners of overdue, failed, or out-of-tolerance equipment.
- Support equipment inventory, status reconciliation, and audit preparation.
Compliance Responsibilities
- Follow GMP requirements, company SOPs, safety procedures, and data-integrity principles.
- Maintain accurate, complete, legible, and traceable records.
- Ensure only approved and released materials are used in GMP operations.
- Protect confidential company, client, and product information.
- Participate in audits, inspections, inventory reviews, and quality investigations.
- Escalate material, sample, equipment, or documentation issues promptly.
Qualifications
Minimum Requirements
· High school diploma or equivalent.
· Strong organizational skills, attention to detail, communication, follow-through, and a dependable work ethic.
· Proficiency in Microsoft Office, particularly Excel and Outlook.
· Ability to manage multiple priorities, learn new processes, and work effectively with cross-functional teams.
· Ability to maintain accurate records and follow established procedures.
Preferred Qualifications
· Associate’s or Bachelor’s degree in science, supply chain, operations, or a related field.
· Experience in material management, inventory control, warehouse operations, laboratory support, manufacturing, or quality-related activities.
· Familiarity with sample tracking, calibration scheduling, and good documentation practices.
· Experience in a pharmaceutical, biotechnology, CDMO, laboratory, manufacturing, or GMP-regulated environment is preferred but not required.
· Experience with ERP systems, electronic quality systems, inventory systems, or calibration-management systems is a plus.
Physical Requirements
· Ability to work in warehouse, laboratory, office, and GMP production areas.
· Ability to lift and move materials or packages up to 40 pounds.
· Ability to follow gowning, PPE, and safety requirements.
· Ability to work with chemical materials and in temperature-controlled storage areas
Pay: $20.00 - $28.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Work Location: In person
