Senior Specialist, Manufacturing Labels & Issuance

Bristol Myers Squibb•Bothell, WA

13d•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 developing, performing, and maintaining a GMP compliant clinical and commercial batch documentation and label issuance and control process. The Manufacturing Labels & Issuance (MFG LI) Senior Specialist will work proactively to identify and address any batch record and label control compliance issues, own and update procedures within their functional area, and manage daily issuance activities to ensure on-time delivery.

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.
Strong technical writing skill set
Innovative, proactive, and resourceful
Quality and continuous improvement mindset
Ability to multitask in a fast-paced environment
Collaborate with cross functional departments to help team deliver time sensitive projects on time
Strong project planning skills
Strong computer skills with MS Office (e.g. Word, Excel, and Adobe/Kofax) and with Quality Systems (e.g. Veeva Document Management System, Quality Management System)
Strong knowledge of cGMPs
Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
Bachelor's degree from an accredited higher learning institution or equivalent is preferred.
A minimum high school diploma and/or equivalent combination of education and experience is required.
3+ years of experience in a cGMP/FDA regulated environment and understanding of manufacturing best practices.
Current experience in document management.

Nice To Haves

Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence is highly desired.

Responsibilities

Contributes to BMS culture and values.
Serves as a point of contact for site functional areas regarding MFG LI tasks.
Provides support and guidance to groups regarding label and record issuance initiatives and deliverables.
Issuing production labels, batch records, and other controlled documents to support manufacturing operations.
Assist Manufacturing Manager with maintaining the label issuance rooms.
Leads process improvement projects and initiatives for the MFG LI team.
Writes and maintains the MFG LI procedures and participates in the development and deployment of MFG LI business process tools.
Review and approve document change requests.
Coordinates with site scheduling regarding incoming and upcoming work.
Solves complex technical problems; takes new perspectives using existing solutions.
Communicate daily with Manufacturing Manager regarding team deliverables, task and project status updates, escalations, deviating events, etc.
Role models the culture of compliance and delegates tasks as appropriate.
Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements.
Assist with training and onboarding MFG LI personnel.
Supports internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit. Assist with document retrieval/organization support during regulatory inspections.
Provides daily communication to customers, management and stakeholders on the status of team deliverables.
Issues production batch records and labels to support manufacturing operations and ensures delivery on time.
On-call responsibilities to support business needs.

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.

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