QA Release Specialist M/V/X

Description de la fonction

QA release Specialist is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes paper/electronic batch record reviews related to the manufacturing of viral vector and autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Job duties are performed within a team according to an assigned, production shift schedule.

• Reviews documentation for all manufacturing activity execution in accordance with good documentation practices.
• Independently executes paper/electronic batch record review associated with commercial; development; and engineering production.
• Performs duties under limited supervision and according to standard operating and manufacturing procedures.
• Contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines.
• Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.
• Implements appropriate corrective and preventive actions by investigating non-conformances in a timely manner.
• Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
• Perform tasks in a manner consistent with the safety policies; quality systems and cGMP requirements.

Profil

• A Degree in Science, Information Science or equivalent technical discipline is required.
• A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility,preferably in quality assurance, manufacturing compliance,clinical quality, or cell therapy. 
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Great attention to detail and ability to follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
• Good written and verbal communication skills are required.
• Ability to collaborate well with stakeholders; customers and peers.
• The successful candidate must maintain written records of work in the form of notebooks; technical reports and protocols.
• Flexible to work on weekends; as needed.
• Dutch and technical English

Compétences linguistiques

• Anglais (atout)

  • Comprendre : Indépendant - (B1)
  • Écrire : Indépendant - (B1)
  • Lire : Indépendant - (B1)
  • Parler : Indépendant - (B1)

• Néérlandais (atout)

  • Comprendre : Elémentaire (A)
  • Écrire : Elémentaire (A)
  • Lire : Elémentaire (A)
  • Parler : Elémentaire (A)

Avantages du poste

. A contract for an indefinite duration.

. A gross salary (based on level and relevant expercience).

. Meal vouchers . Group Insurance

. Hospitalisation Insurance . Supscription for your smartphone up to maximum 20 euros per month

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