Global Quality- External Manufacturing-Regulatory Compliance Co-Op

  • Opportunity Profile:
    • Bristol-Myers Squibb Global Quality Co-Op:  Jan – Jun 2019
      Opportunity Profile: External Manufacturing Co-Op       
      Major(s):  Chemistry, Biology, Pharmacy, Chemical Engineering, Biotechnology
      Year of Individual Requested: Junior, Senior, Masters
      Location of Assignment(s):                         New Brunswick, NJ
      Duration of Assignment(s)                          6 months         
      Required skills:
      • Must be enrolled in school the semester of and/or during the co-op assignment and must be eligible to work full-time, 40 hours, from January- June 2019.
      • Must have strong analytical, interpersonal, communication, organization, and project management skills.
      • Must demonstrate the ability to present ideas, issues, and observations into a clear and useful format, and balance several projects in a fast-paced team environment.
      • Must have the ability to collect, analyze, and integrate information by leveraging appropriate PC/systems technology including Word, Excel, Access and PowerPoint.
      • Must be able to adapt to rapidly changing environment and circumstances demonstrating flexibility, tolerance and sense of urgency.
      Project Description:
      • Provides Quality Compliance support for Contract Manufacturing Operations (CMOs).
      • Primary responsibility is to support Quality Compliance Associate Director with management of quality agreements, management of market action fact finding meetings and audits and inspections of External Manufacturing Americas.
      • Involved in Regulatory Compliance projects with External Manufacturing Team members and managing project timelines
      Key Deliverables at Project Completion:
      • On time delivery of quality agreements per annual plan
      • Gap analysis of supplier quality agreements required and their status.
        Key Learnings:
      • The intricacies and importance of quality compliance in the pharmaceutical arena.
      • Project and data managment