Product Quality Specialist

6 days ago

Singapore beBeeQuality Full time $80,000 - $120,000

We are seeking a Quality Assurance Specialist to join our team. This role is responsible for ensuring the quality of our products and processes.

Job Responsibilities:
  • Support in managing day-to-day operating expenditures against budgets to ensure efficient usage of resources.
  • Support the design and development of quality procedures, processes, and standards to align with quality policy and local regulatory guidelines.
  • Provide technical assistance to production on quality and process improvements, and perform troubleshooting when necessary.
  • Responsible for writing and/or updating all relevant documentation for project activities.
  • Support the quality manager during internal and external audits.
  • Conduct QC tests for every batch of raw materials, in-process and finished products.
  • Execute the technical transfer and validation protocol for QC assays.
  • Assist in implementing new assay methodologies and associated instrumentation.
  • Properly issue and file documents in accordance with GxP requirements.
  • Perform equipment monitoring and basic housekeeping.
  • Maintain inventory and submit purchase requests as needed.
Required Skills and Qualifications:
  • Degree in biomedical science or related discipline.
  • 1-3 years working experience in QA/QC role or relevant work experience in similar manufacturing industry or cleanroom environment.
  • Proven experience in cGMP, FDA regulations, and ICH Guidelines regarding the manufacture of biological products.
  • Good knowledge in quality assurance tools, concepts, and methodologies.
  • Experience in writing and/or reviewing GxP documents to ensure good documentation, data integrity, GxP, and regulatory requirements are met.
  • Experience in cell/gene therapy is preferred.
  • Expertise in cell culture, flow cytometry, and molecular biology.
  • Self-initiated, able to work independently and in a team.
  • Able to communicate at all levels.

GxP

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