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Specialist
QC Analytical, PM shift
Posted on 7/27/2022
INACTIVE
Locations
Devens, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Data Analysis
Management
Writing
Requirements
  • Bachelor's degree required, preferably in Science. Advanced degree preferred
  • 2+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment
  • Hands on experience with various bioanalytical techniques (cell based assays, flow cytometry, ELISA, qPCR)
  • Scientific knowledge in the characterization, validation and transfer of bioanalytical methods preferred
  • Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements
  • Technical writing skills
  • Problem-solving ability/mentality, technically adept and logical
  • Ability to work in a high-paced team environment, meet deadlines, and prioritize work
  • Ability to communicate effectively with peers, department management and cross-functional peers
  • Knowledge of LIMS and laboratory data analysis systems preferred
Responsibilities
  • Perform method transfer/validation and routine testing of in-process, final product, and stability samples
  • Use scientific principles to assist with analytical testing methods and the proper use of laboratory equipment
  • Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner
  • Review all data in accordance with applicable procedures and cGMP requirements
  • Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs
  • Train new analysts to general job duties
  • Support document revision, project, CAPA, and investigation/deviation related tasks
  • Perform assigned tasks within a CAPA, deviation, or project
  • Participate in projects and continuous improvement efforts
  • Perform other tasks as assigned
  • Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions. This position works the following shift schedule
  • PM Shift: Wednesday to Saturday 2 PM - 12 AM
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company mission
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.