Senior Specialist, Quality Assurance Label Control

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 rich in diversity. Take your career farther than you thought possible.

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At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Quality Assurance Label Control Senior Specialist at the Summit, NJ Cell Therapy manufacturing facility is responsible for supporting site Label Control activities at Summit in accordance with BMS policies, standards, procedures and Global cGMPs.  Functional responsibilities include performing in-process and drug product label printing activities; ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Development and Operations (CTDO).

Shift Available:

• Wednesday - Saturday, Onsite Day Shift, 6:30 a.m. - 4:30 p.m.

Responsibilities:

• Supports all activities for the Quality Assurance Label Control group.

• Responsible for issuing clinical and commercial in-process and final product labels for labeling operations.

• Responsible for ensuring accurate printed information on labels in compliance with health authority requirements.

• Coordinates with production teams to ensure timely issuance of labels.

• Performs training of label control and issuance requirements for internal personnel as needed.

• Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required.

• Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.

• Provides support during internal and health authority inspections and audits of facility.

• Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.

• Performs supplemental investigations/projects as required by Management.

• Maintains knowledge of current GMPs and regulatory guidelines.

Knowledge & Skills:

• Must have an advanced knowledge and experience with GMP, Quality, and compliance.

• Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills.

• Requires moderate direction to complete more complex tasks; completes routing tasks with little or no supervision.

• Must be time organized and possess an independent mindset.

• Good understanding of electronic document management and manufacturing execution systems.

• Has advanced computer skills to increase department’s productivity, as well as broadening technical and scientific knowledge.

• Confident in making decisions for non-routine issues.

• Is recognized as an Subject Matter Expert within the group.

• Routinely recognizes and addresses quality opportunities to improve overall process/project efficiencies.

• Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.

• Builds relationships and effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. R