Materials Control Associate III

Catalent•Harmans, MD

3d•$26 - $31•Onsite

About The Position

The Materials Control Associate III supports GMP materials control and warehousing operations for a Phase II/III biopharma manufacturing facility. The role handles materials receiving, processing, inventory control, and distribution while ensuring compliance with Good Manufacturing Practices and applicable regulatory requirements. The position is based at Catalent’s Harmans/BWI campus in Maryland, a 100% onsite, FDA-licensed CGMP gene therapy manufacturing site. The facilities support Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines.

Requirements

High school diploma and at least 4 years of relevant warehousing operations experience.
Experience coordinating and integrating warehousing activities with manufacturing and other departments, including QA and QC, to maintain schedules.
Experience shipping materials requiring special conditions, such as temperature control and hazardous-material handling.
Experience with electronic inventory control systems.
Proficiency in MS Outlook and Excel.
Documented training and certification in handling hazardous materials.
Ability to work independently as a mature professional.
Strong desire to learn.
Ability to walk, stand, bend, reach, push, and pull for extended periods.
Ability to lift and carry up to 40 pounds.

Responsibilities

Manage GMP material receipt, inspection, distribution, reconciliation, and inventory control in accordance with approved procedures and regulatory requirements.
Review and maintain materials control documentation, including material specifications, receipt inspections, inventory records, and request forms.
Oversee labeling control and accountability processes to maintain traceability and GMP compliance.
Receive, store, and control GMP materials and company-generated inventory, including cell banks, bulk proteins, and other critical materials.
Partner with Quality Assurance on material quarantine and release activities, and support deviation, CAPA, and Change Control processes.
Assess Materials Control operations, identify process improvement opportunities, and implement best practices to improve efficiency and compliance.
Generate, revise, and maintain GMP documentation, including Standard Operating Procedures and related quality records.
Support internal, regulatory, and client audits and inspections by preparing documentation, addressing findings, and demonstrating compliance.
Maintain warehouse organization, cleanliness, safety, and raw material integrity by following established quality and safety controls.
Collaborate across functions to support project objectives, train junior staff, and provide materials management expertise for GMP and pre-clinical operations.
Perform additional duties as directed.