Associate II, Materials Control
About The Position
The Material Control Associate II supports GMP materials control and warehousing operations for a Phase II/III biopharmaceutical manufacturing facility. The role handles materials receiving, processing, inventory control, and distribution while ensuring compliance with GMP standards. The position is based fully onsite at Catalent’s Harmans/BWI campus in Maryland and works Monday through Friday, 8:00 a.m. to 5:00 p.m. The Harmans/BWI campus includes an approximately 200,000-square-foot FDA- and EMA-approved facility with CGMP manufacturing suites, fill/finish, central services, testing laboratories, and a warehouse. A second facility is under development and is planned to include additional CGMP manufacturing suites and cold-storage warehousing. The facilities support Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral-vector-based therapies and vaccines. The associate reviews and generates GMP documentation, participates in receiving and distributing materials, maintains inventory records, supports audits and inspections, collaborates with Quality Assurance and other departments, and helps maintain a safe, organized warehouse. The role works under general supervision toward project goals and may assist with pre-clinical projects and training junior personnel.
Requirements
- High school diploma and at least 2 years of relevant warehousing operations experience.
- Experience shipping materials requiring special conditions, such as temperature control or hazardous handling.
- Experience with electronic inventory control systems.
- Proficiency in Microsoft Outlook and Excel.
- Documented training or certification in hazardous materials.
- Ability to work independently.
- Strong desire to learn and grow.
- Ability to walk, stand, bend, reach, push, and pull for extended periods.
- Ability to lift and carry up to 40 lbs.
Nice To Haves
- Previous experience working in a GMP environment.
- Experience performing cycle counting, inventory adjustments, location control, lot and expiry management, and maintaining inventory accuracy.
Responsibilities
- Review GMP materials-control documentation, including material specifications, receipt inspection forms, inventory records, and item request forms.
- Assess materials-control operations and recommend improvements.
- Generate GMP documentation, including Standard Operating Procedures.
- Participate in receiving GMP materials, resolve discrepancies, and verify vendor documentation against Catalent requirements.
- Distribute materials for GMP operations according to approved procedures and assist with reconciliation after client campaigns.
- Compile and maintain inventory records.
- Receive and manage Catalent-generated materials, such as cell banks and bulk proteins.
- Assist with internal audits and participate in regulatory and client inspections.
- Work under general supervision to meet project goals.
- Collaborate with Quality Assurance to quarantine and release GMP materials promptly.
- Maintain warehouse organization and cleanliness.
- Assist in training junior personnel.
- Work with various departments and support pre-clinical projects as needed.
- Ensure compliance with safety guidelines.
- Perform additional duties as directed.
Benefits
- Competitive paid time off and 8 paid holidays.
- Medical, dental, and vision benefits effective on the first day of employment.
- Tuition reimbursement.
- Potential for career growth.
- Defined career path and annual performance review and feedback process.
- Bonus.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
