Beatrice Despointes

About Beatrice Despointes

I’m a hands-on, detail-driven Quality professional with 10+ years of experience ensuring product quality and regulatory compliance in the pharmaceutical and medical device industries.My expertise includes validation (IQ/OQ/PQ, TMV), audit readiness, CAPA investigations, and laboratory operations under cGMP, FDA 21 CFR 210/211/820, and ISO 13485/14971 standards. I’ve supported cross-functional teams in method transfers, process improvement, risk management (FMEA), and quality documentation across design transfer and manufacturing environments.I’m known for being a proactive problem-solver, a collaborative team player, and a mentor who thrives in fast-paced, regulated settings.Let’s connect if you\'re looking for a Quality Engineer or Compliance Leader passionate about improving systems, ensuring audit-readiness, and supporting high-quality product delivery.

Experience

1. Quality Engineer

   安捷伦

   Aug 2025 — Present · Cedar Creek, TX, US

   Ensure compliance and process adherence through thorough batch record review and approval for genomics product release.• Review and approve preventative maintenance, calibration, and IQ/OQ/PQ documentation for process and equipment validations in accordance with quality system requirements.• Develop, implement, and monitor CAPA action plans to address nonconformances and drive long-term corrective and preventive improvements.• Investigate and close NCRs related to product, procedural, out-of-tolerance (OOT) calibrations, and equipment deviations.• Review and approve deviation requests to support continued production while assessing risk and maintaining compliance.• Promote continuous improvement by strengthening documentation standards and reinforcing Good Documentation Practices (GDP) across operations.

Education

• Texas A&M Health Science Center

  Post-Doctoral Fellow, Analytical Chemistry

• Stanford University

  Doctor of Philosophy - PhD, Biophysics

• Louisiana State University

  Bachelor's degree, Biochemistry

Skills

• Manufacturing Quality
• Protein Purification
• Protein Chemistry
• Sds-Page
• Hplc
• Cell
• Microbiology
• Quality Assurance
• Protein Expression
• Fplc
• Fluorescence Spectroscopy
• Site-Directed Mutagenesis
• Ion Chromatography
• Cgmp Manufacturing
• Enzyme Assays
• Online Tutoring
• Protein Characterization
• Protein Engineering
• Size Exclusion Chromatography
• Ion Exchange Chromatography
• Uv-Vis Spectrophotometry
• Circular Dichroism
• Protein Nuclear Magnetic Resonance (Nmr)
• Maldi-Tof
• Capillary Electrophoresis
• Lyophilization
• Centrifugation
• Ph Meter
• Nanodrop
• Titration
• Enzyme Activity Assays
• Recombinant Dna Technology
• Standard Dna Manipulation
• Contructiion of Expression Vectors
• Dna Sequencing
• Prokaryotic Expression