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QC Scientist
Ref No.: 18-28420
Location: Andover, Massachusetts
Job Title: QC Scientist
 
  • The Quality Control Analytical group is seeking a highly motivated candidate to provide testing support for the commercial Polysaccharide product in the cGMP quality control analytical testing laboratory. The testing includes various instrumental techniques including UV-VIS, HPLC, SEC-MALLS and NMR. The candidate will also be expected to support other QC Analytical business activities, as needed.
  • B.S. in Biology, Chemistry or related scientific discipline with a minimum of 2 years of related laboratory experience.
 Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) testing will be required to support manufacturing operations.

Key responsibilities:
  • Perform analytical testing of product samples.
  • Identify basic technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems, and participate in investigations for resolution and correction.
  • Participate in continuous improvement efforts within QC Analytical. Utilize continuous improvement tools.
  • Record and maintain all related data and records in adherence to cGMP and quality procedures.
  • Perform laboratory support functions and maintain work area in a neat and orderly manner.
  • Perform work in a manner consistent with company safety policies and procedures.
  • Participate in company culture based programs.
  • Most daily interactions will be with other QC Scientists
  • Regular meetings with QC Manager
  • Occassional interaction with other functions: Manufacturing Operations, Quality Assurance, Instrument Validation, Investigation Support
 
Position Comments visible to MSP and Supplier:              QC Scientist
  • at least 2 years of experience
  • 80% Lab 20% Business activities
  • Analytical Lab testing
  • write and review assays, get Lab instruments ready, help with support activities in the lab, etc.
  • LIMS experience is a plus
  • NO masters or PhD
  • science related background/ degree
  • GMP experience is must
  • GMP lab experience
  • GMP regulation experience
  • Date integrity, compliance awareness
  • enthusiastic, team player, willing to learn
 
Additional Skills:             
 
  • Preferred laboratory experience includes UV-VIS, HPLC, SEC-MALLS and NMR
  • Strong oral and written communication skills
  • Knowledge and understanding of cGMP and industry standards
  • Proficiency with computer systems (Microsoft Office applications, LIMS, etc.).
  • Experience working in cGMP USP/EP/JP, regulatory environment strongly preferred
  • Normal lifting, sitting, standing and walking requirements to facilitate testing in a laboratory environment.  
What is the minimum education experience required?:
  • B.S. in Biology, Chemistry or other related scientific degree with 2 years experience