Position Summary
This role supports cGMP Manufacturing Operations for the BMS Bothell site, including the coordination, issuance, reconciliation, and management of production labels and records for the Bothell Manufacturing Logistics & Services team (Cell Therapy Operations).
Duties/Responsibilities
- Issue production labels, batch records, and other controlled documents to support manufacturing.
- Coordinate work activities to support manufacturing.
- Manage an electronic document system: review/approve document change requests, troubleshoot, and release documents.
- Execute operations per SOPs and work instructions.
- Execute transactions/process in applicable electronic systems.
- Author controlled documents and deviations.
- Demonstrate strong practical knowledge; represent the department in collaborations.
- Contribute to safety/quality/GMP compliance; role model compliance.
- Complete and deliver training on SOPs/work instructions; train for proficiency in process systems.
- Solve technical problems; identify and propose innovative solutions.
Reporting Relationship
Reports to Supervisor, Manufacturing Labels & Issuance.
Qualifications
- Extensive knowledge of SOPs and cGMPs; ability to work/manage in a regulatory environment.
- Aptitude for engineering principles and manufacturing systems.
- Adaptable to a fast-paced, complex, changing environment.
- Quality Systems knowledge: deviations, SOP revisions/creation, CAPA management.
Education
- Associate or bachelor’s degree in a related field preferred.
- Minimum high school diploma/equivalent required.
Experience
- 1+ years of experience in a cGMP environment and manufacturing best practices.
Schedule
Wednesday–Saturday, 1:00pm–11:30pm.
Compensation (Bothell, WA)
$33.67–$40.80 per hour (plus possible incentive based on eligibility).
Benefits
Health coverage, wellbeing support, and financial protection including 401(k), disability, life insurance, and related programs; Paid Time Off.