Quality Control Analyst

Practice Area bioscience
Job Family Quality Assurance
Job Type Contract To Perm
Location Greater Boston


One of our well-known Biotech clients is seeking an experienced Quality Control Analyst. The QC Analyst will be responsible for biological/chemical evaluation and all other analytical activities regarding the development of final products, intermediate products, raw materials, and production facilities. Please apply today if you think that you are the ideal candidate for the Quality Control Analyst position. 


Responsibilities:

  • Operates analytical instrumentation
  • Support product development, release and stability
  • Perform chemical and physical analyses of raw materials, in-process materials and drug products
  • Analyze and compile data for trending and reporting into regulatory filings
  • Participate in Laboratory/Quality investigations as well as the construction/revision of SOPs
  • Monitor and maintain equipment calibration and operation status
  • Responsible for examining and updating testing procedures, protocol, log books and checklists
  • Propose corrective solutions to resolve issues regarding instruments and test executions
  • Provide support and organize work flow to efficiently accomplish objectives
  • Complete performance reviews and evaluations as necessary

Requirements:

  • Must have a Bachelor’s Degree in Physical or Chemical Sciences (life sciences)
  • Must have at least 5-8 years of experience in a cGMP (good manufacturing practices) regulated environment
  • Demonstrated Chromatography skills
  • Previous experience operating analytical instrumentation
  • Extensive experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data and statistical analyses
  • Leadership skills
  • Ability to author investigations to determine root causes of OOTs and/or OOSs according to cGMP standards 


Position ID: 37566