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QC Expert (M/F)

June 23rd 2020

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 to the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, MaSTherCell’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.

Mission Description

In order to fulfill his/her role, the Quality Control Expert :

  • Is an active member of back-end team.
  • Maintains open and effective communication with all QC team members and with other departments (Production, QA, Project Management, and Technical Service).
  • Respects MTC’s values, QC department vision and mission, and QC Chart.
  • Participates actively to the weekly team meeting.
  • Works to keep department KPI in green.
  • Follows the needed training on due time.
  • Performs his/her duties and documents his/her work according to MTC’s current procedures and GMP rules.
  • May be the EHS (Environment - Health and Safety) support for the QC department.
  • Drafts generic QC documents (INS, PRO, FORM, and SPEC).
  • Initiates Deviation, OOS, CHC linked to his/her work, performs investigations and implements CAPA.
  • Takes part in new tests implementation/improvement under the supervision of QC Project Leader/ QC Supervisor.
  • Takes part in analytical method validation under the supervision of QC Project Leader/ QC Supervisor.
  • Double checks data generated by other operators, for which she/he is allowed to.
  • Respects the safety rules within the laboratory.
  • Warns immediately the QC Supervisor/ QC Project Leaders/ the Head of QC in case of problem or failure or security issue.
  • Takes part to internal and/or external audits, if necessary.
  • Is the back-up of QC Support.
  • Assists the QC Support in daily maintenance of the laboratory (bench and floor cleaning, waste evacuation, general aspect, etc.).
  • Assists the QC Support to perform on due time routine and planned maintenance, calibration, qualification of equipment in the QC department.
  • Assists the QC Support for shipment for the QC department.
  • Assists the QC Support in the management of routine QC reagents stock level.
  • Assists the QC Support in the environmental monitoring.
  • Assists the QC Support in ordering adequate material, reagents, consumables and ensures its availability in due time.

QC processes improvement:

  • Reviews QC processes and proposes improvement.
  • Checks respect of QC processes within the laboratory by the QC team.

 
Outsourcing activities:

  • Finds adequate subcontractors, if necessary.
  • Drafts documentation associated to subcontractor validation.

Raw material strategy:

  • Defines raw material testing strategy according to clinical phase.

Equipment:

  • Drafts documentation associated to installation, use and qualification of QC equipment.
  • Contacts suppliers and manufacturers.

Environmental monitoring:

  • Drafts semi-annual EM report.
  • Participates to EM meeting.
  • May be responsible of EMS for QC.

Training:

  • Drafts and gives training associated to generic activities.
  • May have LLSPOC role (QC representative for training and training management for QC department) and be responsible for MasTherSystem for QC.

 

Candidate profile

OBLIGATORY REQUIREMENTS

  • At least Graduate level in chemistry, biochemistry, biology, etc.
  • At least 1 year experience in cGMP environment.
  • Experience in quality control of cells from human tissue origin is an asset.
  • Experience in microbiological testing is a plus.

USEFUL REQUIREMENTS

  • Organization skills, multitasking.
  • Quality minded, autonomous, rigorous, attentive to details, persevering and pro-active.
  • Technical expertise.
  • Teamwork and teaching skills.
  • Good communication skills and cheerful.
  • Fluency in French.
  • Good reading comprehension and writing skills in English.
  • Computer skills: Microsoft Office.

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

To apply for this job, please send your application on the following link : MaSTherCell