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QC Specialist (m/f)

November 22nd 2019

MaSTherCell is a dynamic and global Contract Development and Manufacturing Organization (CDMO) on a mission to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, MaSTherCell’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

Mission Description

Responsabilities

  • Writing validation/transfer, protocols of analytical methods, certificates of analyses, stability protocols
  • Interpretation of results and writing of analytical methods validation/transfer reports 
  • Taking part to discussion with clients and subcontractors regarding analytical methods
  • Performing QC tests on due time, according to cGMP, current procedures and the QC Manager’s instructions
  • Performing his/her duties and documenting his/her work according to current procedures and GMP
  • Performing on due time : routine and planned maintenance, calibration, qualification of equipment in the QC Department
  • Checking the “conform” status of an equipment prior the test
  • Checking the expiration date of reagents/solutions prior the test
  • Daily maintenance of the laboratory (bench and floor cleaning, waste evacuation, general aspect, etc.)
  • Raw data collection, CAPA implementation, Drafting QC documents
  • Set up of new QC tests
  • Declaring and initiating deviation, OOS linked to his/her results
  • Taking part to audits when necessary
  • Taking part in technology transfer from the client (may include meetings and observation of QC test on the customer’s premises)

Candidate profile

Qualifications & Experience

  • At least Graduate level in Sciences 
  • Experience of minimum 1 year in Quality Control, preferably in a biopharmaceutical company 
  • Previous experience in cGMP environment

Skills & Competencies

  • Fluency in French and good reading comprehension and writing skills in English 
  • Microsoft office, ERP system 
  • Rigorous & conscientious 
  • Autonomous and organized 

Offer

  • Full-time position (40h/week)
  • An Indeterminate contract 
  • The opportunity to take part in a growing dynamic biotech company
  • A human-sized working environment with a convivial atmosphere

 

Contact Details

Click on this link to apply: http://bit.ly/2GDZJyN