Under the direction of the Manager of Warehouse & Logistics, the Sr. Logistics Specialist is responsible for leading the daily operations of warehouse activities for the Pleasanton Manufacturing Facility, ensuring operations are compliant with cGMP’s and safety guidelines. Responsibilities include the receipt, storage, inventory management, and distribution of cGMP/Non GMP materials, samples, supplies and equipment.
The Sr. Logistics Specialist ensures all activities within span of control meet or exceeds Gritstone Oncology’s standards and meet full compliance of all applicable regulatory governing (e.g., FDA, EU, USDA, DEA, and DOT, etc.). In addition, this position is accountable for ensuring safe, cost-effective, and efficient warehouse and supply operations.
This role will lead the daily operations of all shipping & receiving including cGMP receipt and distribution activities. Hands on and direct support across functions is necessary as set forth by the Warehouse Manager.
This position will assist in the creation of procedures, plans and documentation as associated with the Warehouse & Logistics functions.
Summary of Essential Job Functions:
- Perform administrative and/or physical tasks involved in the shipping, receiving, storage, and distribution of GMP/Non-GMP materials, samples, supplies and equipment
- Support the implementation of departmental operations, strategies, policies and procedures in accordance with all applicable governing bodies including but not limited to FDA, EU, USDA, DOT, CBP, OSHA, and in alignment with all Company policies, procedures, goals and objectives
- Perform all activities of the logistics and warehouse functions to enable a compliant cGMP manufacturing site. Implement and administer all systems and processes for maintaining control of 1) inventory and transaction accuracy, 2) warehouse and controlled temperature storage methods and facilities, and 3) domestic and international transportation programs, housekeeping, pest control and GMP compliance
- Maintain appropriate training to properly perform job associated roles/responsibilities and operate in a safe and compliant manner
- Write and review reports upon request. Perform, document and review change controls and investigations within area of responsibility
- High school diploma or equivalent
- Requires formal training in supply chain management, logistics, or closely related discipline
- Requires a minimum of five (5) years’ experience that includes: in-depth understanding of cGMP logistics operations, purchasing and inventory management in the Pharma/Biotech field or relevant field
- Must possess a minimum of three (3) years supervisory or management experience.
- Cold Chain experience required
- Strong knowledge of Quality System Process: CAPA, Deviations, Change Controls required
- Experience managing critical and complex projects
- Must possess excellent attention to detail and analytical thinking
- Strong goal-setting, team leadership, mentoring and professional development skills required
- Strong ability to influence in a team environment and collaborate with peers
- Must have a working knowledge of Trade Compliance responsibilities, on both the import and export sides of the logistics business
- Must have excellent technical writing ability, oral and written communication skills
- Experience / ability to understand and develop procedures and other controlled documents
- Strong knowledge and understanding of software packages and technologies used in a typical logistics operation, specifically Microsoft Office
- 3PL experience
- Working experience and knowledge of applicable regulatory requirements (FDA, EU, FAA, IATA, DOT, Customs, and OSHA)
- Performs other duties as required
- Must be able to obtain Forklift Certification within 12 months of hire
- Must be able to occasionally lift, up to 50 lbs
- Must be able to push and pull up to 125 lbs. with a pallet jack
- Must be able to climb a ladder and stairs
- Some travel between Company sites may be required