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Quality Control Reviewer (M/F)

December 16th 2020

Founded in 2000, Caprion partners with the largest pharmaceutical and most prominent biotech companies. In 2019, under the leadership of the leading specialized private equity firm Arsenal Capital Partners, Caprion joined forces with HistoGeneX, creating an integrated leader in precision medicine and biomarker development. The combined businesses partner with the pharmaceutical industry to accelerate precision medicine, supporting the entire drug development cycle, from preclinical through late stage clinical trials and companion diagnostics.

Mission Description

Key Responsibilities

  • Perform QC review on experimental paperwork in timely fashion.
  • Review data (tables, forms, calculations, etc.) and reports, as assigned;
  • Review data tabulation and study related documents;
  • Report findings to immediate supervisor to identify root cause and improvement opportunities;
  • Help in implanting good quality control practices;
  • Prepare the documentation to be transferred to the archives at study finalization;
  • Review SOP/CSP;
  • Complete tasks in compliance with GLPs, driving documents and current procedures;
  • Work in collaboration with the Principal Scientists and Research Assistants to deliver quality data on time;
  • Applies and train personnel on Good Documentation Practices (GDP);
  • Train personnel on QC review, as needed.

Other Responsibilities

  • Performs biobanking-related activities (sample reception, tracking and inventory) in compliance with applicable procedures;
  • Performs other duties as assigned.

Special Conditions of the Current Position

  • Must accept to perform duties or supervise activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous virus such as HIV, HCV, or CMV;
  • Employee is personally responsible for following Health and Safety guidelines/instructions.
  • This position can involve evening and/or week-end work.

Candidate profile

Education

  • B.Sc. or M.Sc. in Life Sciences

Experience

  • Experience level can vary, however, a minimum of 2 years of industry experience in a similar position is required.

Knowledge Requirements

  • Thorough knowledge of GLP and GCLP regulations;
  • Basic knowledge in biochemistry and immunology;
  • Knowledge of Microsoft Office programs, specifically Word and Excel;
  • Knowledge of GCP, GCLP, ISO/IEC 17025 and GMP regulations.

Skill Requirements

  • Strong attention to details;
  • Good organizational skills and ability to prioritize;
  • Strong quality mindset;
  • High degree of initiative, sense of urgency and flexibility;
  • Excellent spoken and written communication skills in English and French

Offer

For more informations please contact to Caprion

Contact Details

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