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Quality - Quality Records Specialist

Bristol Myers Squibb · Summit, NJ · Yesterday
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About the role

This position will work independently and with the team in supporting QA oversight of CTLs for CTO Vector External Manufacturing operations. The role is accountable for oversight of routine Quality responsibilities related to outsourced testing, Deviations, CAPAs, Change Controls, Certificate of Analysis/Certificate of Testing (CoT/CoA) generation to support the release of vector in a timely manner for commercial, clinical, and early development programs. This role will partner cross functionally with Global Product Quality (GPQ), ExM, Manufacturing Science & Technology (MS&T), Analytical Science & Technology (AS&T), Supply Chain (SC), and teams within Vector External Manufacturing Quality to provide QA oversight of CTLs. It also ensures CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits leveraging Quality and risk-based principles.

Responsibilities

  • Initiation, facilitation, and tracking of quality records from external partners.
  • Respond to challenges and additional workload in an efficient, professional, and timely manner.
  • Provide regular communication, quality records metrics, and guidance to management within the External Manufacturing vector organization.
  • Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT).
  • Support CTL GMP audits and regulatory inspections, as required.
  • Author and revise controlled documents such as Standard Operating Procedures, Annual Product Quality Review, and Vendor Quality agreements.
  • Develop, manage, and present CTL metrics and associated corrective action plans to management.
  • Support continuous improvement projects related to Quality oversight of CTLs.
  • Perform all other duties as assigned by management.

Requirements

  • Bachelor’s degree in Science or related discipline.
  • Minimum 3–5 years of experience working in a regulated GxP environment.
  • Experience working with Quality System Records, Change Controls, Deviations, Laboratory OOS and OOT investigations.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Ability to carry out responsibilities in accordance with organizational policies, procedures, and state, federal, and local laws.
  • Ensure compliance with current Good Manufacturing Practices (cGMP), USP, EU, and other global regulatory requirements.
  • Strong technical writing skills and ability to critically review investigations, interpret results, and generate technical conclusions.
  • Ability to routinely recognize quality issues and assess risk.
  • Understanding of continuous improvement and ability to improve the compliance and efficiency of quality records.
  • Strong knowledge of problem-solving methods used to perform Root Cause Analysis.
  • Proficiency in Microsoft Word, Excel, PowerPoint, SharePoint, and Smartsheet management tools.

Skills

  • Active team member in the Virtual Analytical Teams (VATs), including collaboration with Service Relationship Managers (SRMs).

Working Conditions

  • Sitting or standing at a computer terminal for an extended period.
  • Work in a conference room/meeting environment for moderate periods of time.
  • Regular, predictable attendance is required.
  • Flexibility with schedule (weekends, holidays, extended hours) as business demands dictate.
  • Moderate noise, i.e., business office with computers, phone, and printers.

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