Associate I, Warehouse

Associate I, Warehouse
Bothell, WA
12+ Months with a high possibility of extension
Monday–Friday, 9–5

Description:

• The incumbent is responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors and autologous cell therapies. This role works closely with Manufacturing Operations, Quality Control, Quality Assurance, and Supply Chain to establish warehouse operations and all necessary procedures, processes, and systems.

Key role and responsibilities:
Startup Warehouse Operations

• Work collaboratively with Manufacturing, QA, QC, F&E, and Supply Chain on all aspects of warehouse qualification and start-up.
• Coordinate, receive, and organize daily deliveries of start-up equipment and supplies to be ready to move into the facility and/or warehouse.
• Assist with the development and implementation of GMP procedures, policies, and processes related to warehouse operations.
• Assist with implementation of an ERP system for inventory management Day-to-Day Warehouse Operations
• Support manufacturing, warehousing, inventory control, and distribution activities for the Bothell facility in accordance with GMP regulations and related SOPs.
• Receive and appropriately sort, document, label, and store incoming deliveries.
• Update and maintain inventory control system.
• Perform warehouse operations safely, as scheduled, and right the first time to ensure delivery of treatment to patients.
• Maintain the warehouse at a high standard of cleanliness and organization.
• Perform equipment maintenance and calibrations as required.
• Complete and review GMP documentation in a timely manner.
• Maintain appropriate level of training for assigned responsibilities.
• Performs physical cycle counts, reconciling with data storage system.
• Expected schedule (e.g., Monday–Friday, 9–5, 40 hours/week, or if the schedule may vary) Monday- Friday 8-4 to begin and then hours might shift over to shift work including one weekend day as time goes in the contract.
• Skills: Experience with quality management systems (e.g. Deviations, CAPAs, Change Management), inventory management systems (e.g. ERP), and building / equipment management systems.

Knowledge, skills and abilities:

• Proven track record in cGMP environment.
• Fast learner, adaptable, and excellent cross-collaboration and interpersonal skills.
• The desire and ability to work in a fast-paced, hands-on, start-up environment. Client .Version: January 2021

ROLE DESCRIPTION
IATA/ DOT Certification.
PHYSICAL REQUIREMENTS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:
Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.
Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe nonsterile and sterile gowns
SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE:
Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.

Education: High School diploma with 4-6+ years of experience in supply chain or warehouse operations

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