GMP Materials Management Associate
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Job Detail
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Offered Salary 0
Job Description
DUTIES AND RESPONSIBILITIES:
- Manage activities and develop Materials Management Associate I staff.
- Perform materials management activities with cGMP compliance and support regulatory audit readiness.
- Perform hands-on materials management operations including ordering, receiving, inspecting, dispositioning, and stocking of raw material and supplies for cGMP manufacturing of cell and gene therapy products.
- Work with Manufacturing, Quality Control, and Quality Assurance teams and inventory systems to ensure adequate materials are available and released in time to support GMP production.
- Coordinate and ship products, samples, and ensure temperature sensitive material reach their destinations on time and in full.
- Create and/or update raw material/supplies specification as well as develop or modify SOPs for material management processes, as necessary.
- Organize storage rooms, perform cycle counts, data entry to maintain a cGMP inventory system thus ensuring all our departments have adequate access to the materials they need.
- Implement and maintain strict GMP procedures and lead any efforts required to address and close any material deviations or non-conformance.
- Collaborate with Facilities, Manufacturing, Quality Control, and Quality Assurance in supporting internal and external materials management operations, and resolution of issues.
- Perform disposition of all expired materials and maintains applicable documentation.
- Monitor temperature conditions of refrigerators, freezers, and room temperature storage of cGMP materials.
- Generate Master Schedules and tactically ensure material supply supports forecasted production plans.
- Work closely with the internal departments to support lean inventory management and mean material demand needs.
- Drive continuous improvement of supplies, movement, and processes to reduce waste and improve service levels.
EDUCATION AND EXPERIENCE:
- Associate or Bachelor’s degree in life science or supply chain management, or equivalent combination of education and experience.
- Minimum of 4 years’ experience in a regulated materials management environment.
- Knowledge of principles and practices of current Good Manufacturing Practices (cGMPs.)
- Experience in organizing and management of GMP warehouse inventory, specifically in the biotech/pharma/consumer goods industries.
- Strong computer skills with Microsoft Office and the ability to quickly learn new applications.
- Experience with Inventory Management Systems/ERP and OE/5S is a plus.
- Technical working knowledge and/or experience in product packaging or design a plus.
DESIRED KEY COMPETENCIES:
- Comfortable in a fast-paced company environment and able to change direction easily to accommodate the situation at hand, while maintaining a positive attitude.
- Self-organizer, meticulous hands-on habits, keen attention to detail.
- Highly motivated with excellent interpersonal, collaborative, and team-oriented skills to work well with the rest of the organization and build relationships with suppliers.
- Perform other responsibilities to support the needs of the department, as assigned.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- Strong quantitative and analytical skills.
- Ability to understand and execute the company’s mission and values.
- Maintain a high degree of ethical standard and trustworthiness.
- Exhibits and open mindset when approaching challenges and conflict.
- Ability to think and adapt to a rapidly changing environment and demands.
- Working conditions and physical requirements:
- Must be able to lift, carry, push and/or pull 40 pounds of equipment or supplies
- May need to work with hazardous materials
- Able to stand up to 4 hours at a time
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Application ends in 3d 3h 17min