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14 дней назад

QA Associate Cryo

52 000 - 82 685€
Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
Belgium
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
QA Associate Cryo (CAR-T/Quality Assurance): Supporting the EMEA CAR-T quality system and cryopreservation of apheresis material in a state-of-the-art laboratory with an accent on batch release, document control, audits, and GMP/GTP compliance. Focus on reviewing batch records, handling deviations, maintaining quality indicators, and overseeing daily cryopreservation operations in a two-shift regime.

Location: Beerse, Antwerp, Belgium; onsite at the Beerse site. The role requires flexibility to work a two-shift regime after training and qualification in a standard day shift.

Base pay: €52,000–€82,685 annually, plus an annual bonus or sales commissions depending on the applicable plan.

Company

Johnson & Johnson MedTech develops healthcare and Innovative Medicine solutions, including CAR-T therapies for oncology.

What you will do

  • Provide QA oversight of incoming fresh apheresis material for cryopreservation supporting clinical and commercial requirements.
  • Review and release cryopreserved apheresis products and their batch records.
  • Review and approve protocols, SOPs, batch records, validation reports, and other project-specific documents.
  • Prepare for and participate in internal and external audits and inspections, lead responses, and implement corrective actions.
  • Support quality policy implementation, maintain quality performance indicators, and handle deviations.
  • Work cross-functionally with the operational technology team and the QA Cryopreservation Manager.

Requirements

  • Bachelor’s degree.
  • Proficiency in English and Dutch, both verbal and written, is required.
  • Strong communication, problem-solving, documentation, and cross-functional teamwork skills.
  • Previous GMP, GTP, hospital, or blood bank experience is preferred but not required.
  • Must be open to a two-shift work regime.

Nice to have

  • Interest or knowledge in cell therapies and oncology.
  • Good documentation practices.

Culture & Benefits

  • Inclusive work environment focused on individual dignity, diversity, and merit.
  • Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
  • Well-being reimbursement and programs supporting financial, physical, and mental health.
  • Service anniversary and recognition awards.
  • Eligibility for insurance plans may apply depending on location and plan terms.

Hiring process

  • Application and CV review.
  • Short recruitment call for matched candidates.
  • Country-specific checks before starting the role, followed by candidate feedback collection.

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