Bristol-Myers Squibb Company

Quality Control Senior Associate

Devens, MA, US
Feb 20, 2019
Quality, Quality Control
Required Education
Associate Degree
Position Type
Full time

To perform QC analytical testing in support of biologics bulk drug substance manufacturing using defined methods in a cGMP compliant laboratory. Assures test results are accurately recorded and abnormal data or equipment/instrument malfunctions are promptly reported to his/her supervisor

  • Performs routine testing and data review of raw materials samples and, in-process, batch release and stability samples of Bulk Drug Substance in a cGMP compliant environment.
  • Performs routine assays such as UV-VIS Spectrometry, SDS Page, Wet chemical analysis, various HPLC methodologies (e.g. SEC and reverse phase), utility testing (e.g. TOC, conductivity, and gas testing.)
  • Performs sample management including: sample receipt, sample tracking, aliquots preparation, and sample distribution
  • Writes and revises SOPs for managerial review and approval.
  • Aids in troubleshooting equipment and methods and performs some basic troubleshooting techniques.
  • Trains less experienced analysts on routine test methods.
  • Sr. QC Chemistry Associates will work in teams and have continual interaction with members of his/her team as well as other teams throughout the facility in order to exchange information regarding testing completed, in process and planned.
  • All QC Microbiology Associates and Specialists will have daily contact with her/his supervisory staff for work assignments, coaching and general management discussions.
  • Occasional contact with other line management staff relating to specific project responsibilities may be expected.
  • Sr. Associates primarily work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials.
  • Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing facility. Flexibility to work irregular hours and short notice overtime.

  • Knowledge of science generally attained through studies resulting in a B.S. in chemical sciences, a related discipline, or its equivalent is required.
  • A minimum of 2 years relevant experience in Biologics QC laboratory or related biopharmaceutical cGLP or cGMP lab.
  • Good functional experience with common laboratory tools and equipment such as: UV-VIS Spectrometry, electrophoresis, Wet chemical instrumentation and HPLC.
  • A working knowledge of regulatory standards as they apply to biopharmaceutical manufacturing.