Senior Specialist, Quality Assurance Label Control

3 days ago


Akron, Ohio, United States Bristol-Myers Squibb Full time
Join Our Team as a Quality Assurance Label Control Specialist

Bristol Myers Squibb is a leading pharmaceutical company that is committed to transforming patients' lives through science. We are seeking a highly skilled Quality Assurance Label Control Specialist to join our team at our Summit West-NJ facility.

The Quality Assurance Label Control Specialist will be responsible for supporting site Label Control activities at S-12 in accordance with BMS policies, standards, procedures, and Global cGMPs. This includes 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).

The ideal candidate will have a strong background in quality assurance and label control, with a minimum of 5 years of experience in a GMP facility. They will also have excellent communication and problem-solving skills, as well as the ability to work independently and as part of a team.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual who is passionate about quality and compliance, we encourage you to apply for this exciting opportunity.

Key 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.

Requirements:

  • Bachelor's Degree required. An equivalent combination of higher education and experience will be considered.
  • Minimum 5 years of experience in a Quality Assurance role within a manufacturing GMP facility.
  • Minimum of 3 years of experience with labels.
  • MES systems experience highly desired.
  • Oracle experience preferred.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and inclusive work environment.

How to Apply:

If you are a motivated and detail-oriented individual who is passionate about quality and compliance, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter to [insert contact information].



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