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Quality Assurance Specialist

2 weeks ago

Singapore beBeeAnalytical Full time $160,000 - $200,000
Job Description

The Quality Assurance Manager is responsible for ensuring the operational aspects of all analytical testing within the QC Laboratory are performed in a reliable and timely manner. This role requires a high level of expertise in quality systems and practices, as well as excellent organizational and collaborative skills.

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  • Develop, optimize, implement analytical methods, and working procedures for characterization, release, and stability testing of viral vector gene therapy products.">
  • Ensure the quality systems and practices in the laboratory comply with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP), and Quality Management Standards (QMS).">
  • Develop the organization's quality testing policy in alignment with regulatory standards.">
  • Lead and perform lab method validation, transfers of analytical methods from other collaborators/clients, protocol harmonization, and optimization from R&D to Production.">
  • Conduct, review, or approve laboratory investigations and ensure all follow-up actions are completed.">
  • Compile data, generate reports, and perform computations using data analysis software, spreadsheets, graphing, and curve fitting software.">
  • Align with MSAT, Quality, and Production teams on phase-appropriate analytical methods and strategies for in-process and QC release testing.">
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Required Skills and Qualifications:

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  • Ph.D. in Cell and Molecular Biology, Immunology, Biotechnology, Biochemistry, Microbiology, or related fields with 6+ years of relevant experience, or Master/Bachelor's degree with a minimum of 8+ years of relevant industry experience in a cGMP setup.">
  • Prior experience performing viral genome titre, infectivity, potency, host cell protein, and host cell DNA assays are required.">
  • Extensive hands-on experience with development of analytical techniques for characterization and analysis of viral vectors is desired, including: Flow cytometry, qPCR, dPCR, ELISA, SDS-PAGE, Western blot, mycoplasma, sterility, endotoxins.">
  • Experience in the design and optimization of cell-based potency and infectivity assays.">
  • Must have experience facing regulatory, Client & external cGMP audits.">
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Benefits:

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  • Opportunity to work in a fast-paced environment with a highly motivated team.">
  • Chance to develop and implement new analytical methods and procedures.">
  • Professional growth and development opportunities.">
">Key Responsibilities:">
  1. ">
  2. Develop, implement, and optimize analytical methods for viral vector gene therapy products.">
  3. Ensure compliance with regulatory standards and Good Laboratory Practices (GLP).">
  4. Collaborate with cross-functional teams to align analytical methods and strategies.">
  5. Lead and perform laboratory investigations and ensure follow-up actions are completed.">