Charles Lu
- Role
- Director of Quality Assurance at Bioatla, Inc
- Location
- San Gabriel, CA, US
- LinkedIn followers
- 500 followers
About Charles Lu
Executive leader with over 25 years of expertise in all facets of biotechnology…
Experience
Director of Quality Assurance
Mar 2021 — Present
Education
Loyola Marymount University
Bachelors of Science, Biochemistry
1991 — 1996
Skills
- Gamp
- Computer System Validation
- Corrective and Preventive Action (Capa)
- Ich Guidelines
- Iso 13485
- Gmp
- Quality Assurance
- Gxp
- 21 Cfr Part 11
- Validation
- Ema
- Lims
- Quality Control
- Regulatory Submissions
- Fda
- U.s. Title 21 Cfr Part 11 Regulation
- Iso 13485 and 14971
- Glp
- Change Control
- Aseptic Processing
- U.s. Food and Drug Administration (Fda)
- Quality System
- Sop
- Biopharmaceuticals
- Capa
- Fda Guidelines 21 Cfr Part 11, 820, 210, and 211
- Good Laboratory Practice (Glp)
- Standard Operating Procedure (Sop)
- Technology Transfer
- Ema - Ich Guidelines Q7a, Q8, Q9, Q10, Annex 11, Astm E2500, Itil Certified
- Trackwise
- V&V
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