14 дней назад
QA Associate Cryo
52 000 - 82 685€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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