Quality Specialist III

Amsterdam

Neogene Therapeutics are looking for highly motivated individual contributor to join us as a Senior Quality Assurance Officer within Neogene’s Quality Organization.

Responsibilities include, but are not limited to:

The successful candidate will be involved in:

  • Maintenance and Development of the Quality Management System
  • Authoring, review and/or approval of GxP records and documents (both internal and external) including but not limited to master and executed production batch records, investigations, corrective actions, change controls, protocols and reports
  • Issuance of GxP documentation
  • Support of critical material and product disposition documentation
  • Participate in cross functional meetings to support and promote a quality culture within Neogene
  • Quality support to all departments: Laboratory, Supply Chain, Facilities and Engineering, BioIT, Clinical Operations and Analytical development
  • Support to Quality team from external visits, audits and inspections as needed
  • No supervisory responsibilities.

Requirements:

  • Excellent verbal and written communication skills.
  • Excellent organizational skills and attention to detail with ability to prioritise workload
  • Experience with collaborating in a cross-functional working model
  • Ability to function well in a high-paced environment.
  • Self motivated with a supportive approach
  • Proficient with Microsoft Office Suite or related software.
Education and Experience
  • Bachelor’s Degree and 4+ years’ experience in GMP/GCP environment or related field
  • Demonstrated experience of practical Pharmaceutical Quality Assurance
  • Experience of working with early phase clinical trials – preferred
  • Experience of working with novel biologic therapies- preferred
  • May be required to travel approximately 10% of the time

We offer the opportunity to join a highly dynamic biotech company. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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