Bristol-Myers Squibb Company

Quality Control Senior Associate

Location
Devens, MA, US
Posted
Feb 20, 2019
Ref
R1513333_EN
Discipline
Quality, Quality Control
Required Education
Associate Degree
Position Type
Full time
Summary:

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

Responsibilities:
  • 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.


Qualifications:
  • 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.