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GMP Warehouse Associate
3 months ago
The Company
Scorpius BioManufacturing is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. Our facility in San Antonio, Texas specializes in working with start-ups, emerging biotechs, and academic researchers. Scorpius was founded by a serial biotech entrepreneur determined to make small-volume programs a big priority. Clients benefit from decades of expertise taking large molecule drugs to market and can rely on Scorpius to offer Quality, Speed, Flexibility, & Responsiveness.
Position Summary
This position is based in San Antonio, Texas, and directly reports to the Warehouse Manager. The GMP Warehouse Associate will be responsible for supporting warehousing and inventory control activities for both GMP and Non-GMP materials. Responsibilities include but are not limited to receiving, inventorying and transferring materials to Scorpius’ GMP and non-GMP facilities. This individual will support key Supply Chain tasks, necessary to support R&D and clinical operations. The ideal candidate must exhibit attention to detail and good time-management skills to adapt to rapid business goals; be organized, self-motivated, and thrive in a fast-paced and dynamic biotech environment.
Key Responsibilities
- Support day-to-day operations of the GMP warehouse. This includes the responsibility of ensuring the GMP Warehouse remains organized, efficient, and in a state of compliance with applicable regulations and internal SOP’s at all times.
- Physically receive, inspect, and process GMP and Non-GMP deliveries, along with the necessary documentation.
- Reconcile discrepancies and ensure accurate and timely receipts are entered into the ERP system.
- Maintain all systems and documentation in accordance with GDP requirements.
- Inventory management of all GMP/non-GMP materials, including cycle counts, transfers, adjustments, issuances, etc.
- Perform GMP material picking and kitting operations in accordance with internal SOP’s.
- Adhere to manufacturing production schedule to maintain material readiness.
- Collaborate with cross functional departments to coordinate material movement and support manufacturing production schedules.
- Comply with safe handling and storage requirements, cGMP/ISO, site & corporate policies, and environmental/other related regulations.
- Responsible for the coordination and monitoring of all shipments, including the detailed packing and tracking of cold chain shipments per site procedures, IATA/DOT and applicable regulations. Shipments include clinical products, vendor returns for rejected or damaged goods, along with providing shipping/receiving support for internal customers.
- Participate in Investigations, CAPAs, and Change Controls.
- Follow instructions outlined in departmental SOPs.
- Support Authoring/revising SOPs related to the job function as needed.
- Operate a 26-foot box truck, forklift, pallet jacks, and all other warehouse equipment.
- Perform other duties as assigned.
Education & Experience
- Associate or bachelor’s degree preferred.
- High school diploma or equivalent required.
- Minimum 2-3 years’ previous experience in GMP Warehouse Logistics, Distribution and Supply Chain preferred.
- Understanding GMP regulations applicable to warehouse and transportation
- Strong organizational skills and attention to detail handling GMP materials.
- Prior forklift experience. Certification within 90 days.
- Familiarity with Radio Frequency (RF) scanning equipment.
Knowledge & Skills
- Knowledge of Good Documentation practices (GDP).
- Excellent organizational skills and strong attention to detail required.
- Team player with excellent communication skills, both verbal and written.
- Must be able to multi-task in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Has a positive can-do attitude with a friendly approach to all challenges.
- Experience in Microsoft Office Suite (Word, Excel, and PowerPoint), web-based systems, email, and voicemail.
Physical Requirements and Working Environment
- Flexibility to work on weekends, overtime or in rotating shifts if needed.
- This position will work in a Warehouse including temperature-controlled equipment (e.g., -20°ree;C, -80°ree;C, LN2). You will also be exposed to hazardous materials including but not limited to blood, corrosive and flammable chemicals.
- While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 50 pounds.
