QC Analytical Scientist

2 months ago


Rockville, United States Clinical Resource Network (CRN) Full time

Our client is looking to fill the role of QC Analytical Scientist. This position will be fully remote.


Responsibilities:


  • Coordinates quantitative and qualitative analytical testing of developmental, clinical, and commercial pharmaceutical and related products (including raw materials, in-process materials, and finished products) and reporting of results by contract laboratories.
  • Reviews and trends analytical data, including raw data, of developmental, clinical, and commercial pharmaceutical and related products for accuracy and compliance with company and GxP requirements.
  • Monitors stability studies of developmental, clinical, and commercial pharmaceutical and related products tested by contract laboratories.
  • Reviews, enters, and maintains stability data for developmental, clinical, and commercial pharmaceutical and related products.
  • Creates studies in LIMS and enters and reviews data in LIMS.
  • Transfers analytical methods between Japan site, contract laboratories in the US, and other international affiliates.
  • Prepares and maintains QC documentation, including protocols, reports, and test methods.
  • Procures reference materials and monitors reference materials at contract analytical laboratories.
  • Maintains and updates department documents required for regulatory compliance
  • Assists in technical investigations


Required Qualifications:


  • 5 + Years of experience of hands-on Analytical Laboratory testing specific to Pharmaceutical industry
  • BA Degree in related science, ideally Chemistry
  • Familiarity in GMP environment focused on analytical laboratory testing
  • HPLC
  • Dissolution analyses
  • Karl Fischer
  • USP General Chapters
  • MS Office
  • Electronic document management systems – First Doc, GQEDMS, CREDO, etc.
  • Electronic quality management systems – TrackWise
  • Laboratory Information Management System – LIMS
  • Project Management experience


If you meet the required qualifications and are interested in this role, please apply today.


Clinical Resource Network Distinction


CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.


About CRN


Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn.


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