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Environmental Quality Control Analyst

Location:
San Francisco, California, 94116, United States
Posted:
August 15, 2018

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Resume:

ac6oc4@r.postjobfree.com wwong**** 415-***-**** San Francisco, CA

PROFESSIONAL EXPERIENCE

Genentech South San Francisco, CA

Environmental Quality Control Analyst, May 2016 – Present

● Performed QC-related testing using established methods and procedures for Conductivity, Total Organic Carbon (TOC), Limulus Amebocyte Lysate (LAL) assay and Bioburden.

● Performed environmental monitoring and water sampling in manufacturing environments.

● Reviewed and analyzed data, initiating discrepancies and deviations when required.

● Prepared reagents, buffers, and standards to support QC testing.

● Participated in operation & performance qualifications in validation projects.

● Supported the compliance and audit-readiness of operational and QC areas.

● Supported the maintenance and cleaning of lab equipment.

● Coordinated with departments to support business-related activities.

● Ensured current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).

● Record keeping of laboratory media and reagents

● Experience with the analyst and reviewer role in Labware LIMS. Genentech South San Francisco, CA

Inspection/Packaging Operator, March 2016 – May 2016

● Performed Final Inspection on finished product and escalated issues to Supervisor and/or Lead.

● Packaged final products according to Good Manufacturing Practices (GMP).

● Documented and reviewed work performed according to Good Documentation Practices (GDP).

● Supported the maintenance, compliance, and audit-readiness of Final Inspection and Packaging Area.

● Participated in Continuous Improvement Activities (5S). EDUCATION

Certificate Program in Clinical Research Conduct and Management UC Berkeley Extension (Winter 2018)

Bachelor of Science, Cell and Molecular Biology (2015) San Francisco State University, San Francisco, CA

TRAINING/SKILLS

● Experienced in ISO 7 gowning

● Testing in Class II, Type A2 biosafety cabinets

● Performing Environmental Monitoring in Drug Substance and Drug Product (Grade C, Grade C HEPA, Capping Zones, Biozones 3.1, 3.2)

● Experienced with Sievers 900 Laboratory TOC analyzer

● Experienced with Mettler Toledo conductivity meters

● Experienced utilizing DocLink EDMS, and Labware LIMS

● Proficient at performing membrane filtration,

● Proficient at testing Conductivity, TOC analysis, and Color, Odor, & Appearance

● Performing Limulus Amebocyte Lysate (LAL) with BioTek readers and EndoScanV software

● Operation of MAS100 impaction-type air samplers, monitoring viable air particulates

● Operation of Climet NVP particle counters, monitoring nonviable air particles

● Understanding of cGMP, GDP and GLP guidelines for pharmaceutic Wilson Wong



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