Associate II, Manufacturing Labels & Issuance

Bristol Myers Squibb • Bothell, WA

3d • $34 - $41 • 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.
• A minimum high school diploma and/or equivalent combination of education and experience is required.
• 1+ years of experience in a cGMP environment and understanding of manufacturing best practices.

Nice To Haves

• Associate or bachelor's degree in related field is preferred.

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

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 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.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include 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 and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED