Key Responsibilities:
- Perform physical and administrative tasks related to storing and organizing materials, parts, supplies, and equipment.
- Conduct product counts for specific part numbers and maintain accurate inventory records.
- Lift heavy items and operate pallet jacks as needed.
- Stock and move materials to inventory and manufacturing lines.
- Adhere to company policies, procedures, and material control systems to ensure smooth operations.
- Manage non-GXP material orders to meet company needs while maintaining appropriate inventory levels.
- Apply 5S and Lean concepts for efficient warehouse operations.
- Provide regular inventory reporting and maintain an up-to-date inventory tracker.
- Collaborate with Manufacturing and Procurement teams on GMP raw materials.
- Identify materials nearing expiration and take appropriate action.
- Write and review SOPs, forms, and documents related to materials management.
- Support with deviations, CAPAs, and other quality-related activities.
- Assist in maintaining key performance indicators (KPIs) for materials management.
Preferred Experience:
- 3-5 years of controlled warehouse experience, or equivalent training in materials handling.
- Experience in cGMPs and FDA-regulated environments is highly preferred.
- 3-5 years of inventory control experience.
- Knowledge of shipping and receiving processes, with 3-5 years of relevant experience.
- Proficiency in MS Office (Word, Excel) and ERP systems like Oracle, SAP, or Microsoft Dynamics.
- Familiarity with document control systems (e.g., QUMAS).
- Experience with DOT and IATA regulations is a plus.
Required Experience:
- 3-5 years of experience in a controlled warehouse environment.
- Expertise in ERP systems for processing and tracking raw materials and finished goods.
- Ability to write and review SOPs, Forms, and support quality processes such as deviations and CAPAs.
- Working knowledge of cGMPs for biopharmaceuticals.
- Excellent organizational, communication, and interpersonal skills.
- Previous experience working with CRO/CMO partners and QA/QC teams.
Education:
- Minimum high school diploma required.
- Some college or a BA/BS degree with 3+ years of related experience in a cGMP environment is preferred.
Work Environment & Physical Demands:
- Prolonged periods of sitting at a desk, working on a computer.
- Must be able to lift up to 50 pounds occasionally.