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JOB FUNCTION: Scientific
LOCATION: Morris Plains, NJ

MINIMUM EDUCATION: Bachelor's Degree
POSTED: Jul 29, 2020

Our client is in the Bio-therapeutics industry and they are seeking a Quality Control Data Analyst

Salary/Hourly Rate:

Up to $45/hr (Depending on experience)

Position Overview:

The Quality Control Data Analyst will review documentation associated with the operation of a cGMP QC laboratory. Responsibilities  of the Quality Control Data Analyst include application of uniform practices for review of analytical raw data and electronic data in the analytical laboratory supporting batch release, stability, cleaning verification, raw materials release, method qualification and method transfer activities. The Quality Control Data Analyst will perform routine inspection of laboratory documentation for compliance with current industry standards is also within scope.


  • Review cGMP microbiology data generated during testing to support product release, stability and facilities monitoring using HPLC, UPLC, Capillary Electrophoresis and wet chemistry methods
  • Ensure standards for documentation and comply with SOPs (analytical methods and Good Documentation Practices) and industry standards
  • Review laboratory logbooks, labeling and other documentation to ensure conformations with SOPs and industry guidelines
  • Provide technical support for monitoring and evaluating the performance of analytical methods to demonstrate ongoing method suitability
  • Compile and summarize analytical raw data in various physical and electronic report formats
  • Review protocols, analytical reports and certificates of analysis
  • Provide guidance and training to QC personnel to support company training in the procedures used to effectively execute testing
  • May coordinate and track progress of analytical testing internally or at CROs
  • May participate in regulatory agency audits and inspections


  • Strong technical knowledge including an understanding of laboratory procedures, methodology and standards required
  • 3 years of QC analytical laboratory experience is preferred
  • Experience in a regulated biopharmaceutical environment with analysis of biological molecules is preferred
  • 3-5 years of experience testing pharmaceutical products in a GMP-regulated QC laboratory
  • Experience with HPLC / UPLC, spectrophotometers, and capillary electrophoresis is preferred
  • Knowledge of QC laboratory test procedures, cGMP requirements, ICH/USFDA guidelines, raw material analysis, method validation guidelines, analytical method transfers, finished products, and stability testing
  • Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
  • Familiarity with regulatory guidance documents from FDA, EMEA and ICH
  • Must be able to recognize the impact beyond a single site, project or collaboration

Education Requirements:

  • Master’s degree in Biochemistry, Molecular Biology or a related field
  • 3 years relevant experience or Bachelor’s degree
  • 5 years of relevant GMP lab experience with bio-therapeutics preferred


  • Atrium Care Package available

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