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Label & Batch Documentation Specialist (cGMP)

$33.67 - $40.8 per hour

Bristol Myers Squibb

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Position Summary 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. Duties / 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. Reporting Relationship Reports to Supervisor, Manufacturing Labels & Issuance. Qualifications 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. Education Associate or bachelor's degree in related field is preferred. A minimum high school diploma and/or equivalent combination of education and experience is required. Experience 1+ years of experience in a cGMP environment and understanding of manufacturing best practices. Schedule Wednesday – Saturday, 1:00 pm – 11:30 pm. Compensation Overview Bothell – WA – US: $33.67 – $40.80 per hour. The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit Benefits Health Coverage: Medical, pharmacy, dental, and vision care. Well‑being Support: Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial and protection benefits: 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 Unpaid and paid time off policies varying by location and employment status; additional time off may include unlimited paid sick time, up to two 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. Equal Employment Opportunity Statement We are committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations and ongoing support in their roles. All qualified applicants will receive equal consideration for employment. #J-18808-Ljbffr Bristol Myers Squibb

Vacancy posted 4 days ago
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