Associate II, Manufacturing Labels & Issuance

Bristol Myers Squibb•Bothell, WA

16h•Onsite

About The Position

This role is part of the Bothell Manufacturing Logistics & Services team and will focus supporting cGMP Manufacturing Operations for the BMS Bothell site, including the coordination, issuance, reconciliation, and management of production labels and records. Functional responsibilities include all batch label and documentation control activities for Cell Therapy Operations (CTO), including performing and maintaining a GMP compliant clinical and commercial batch documentation and label issuance and control process.

Requirements

Extensive knowledge of SOPs and cGMPs and the know–how to work and manage within a regulatory environment.
Demonstrates aptitude for engineering principles and manufacturing systems.
Adaptable to a fast paced, complex, and ever-changing business environment.
Quality Systems for Deviation, SOP revisions/creation, CAPA Management.
1+ years of experience in a cGMP environment and understanding of manufacturing best practices.

Responsibilities

Issuing production labels, batch records, and other controlled documents to support manufacturing operations.
Coordination of work activities to support manufacturing.
Managing an electronic document system for the Bothell site which includes reviewing and approving document change requests, troubleshooting, and releasing documents to an effective state.
Execute operations as outlined in Standard Operating Procedures (SOPs) and work instructions.
Executes transactions and process in all applicable electronic systems.
Controlled document & Deviation authoring.
Demonstrate a strong practical knowledge in their work.
Can represent department in departmental collaborations.
Contributes to BMS culture and values.
Solve technical problems by taking new perspectives using existing solutions.
Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
Complete training assignments to ensure the necessary technical skills and knowledge
Train for proficiency in process systems and some supporting business systems
Train others on SOPs, Work Instructions to successfully complete manufacturing operations
Identify and propose innovative solutions.
Role models the culture of compliance.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Flexible time off (unlimited, with manager approval, 11 paid national holidays)
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Unlimited paid sick time
up to 2 paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
an annual Global Shutdown between Christmas and New Years Day.