Robin T. Norris
Quality Assurance Specialist
Thurmont,MD
Summary
Eleven years of experience in quality management systems (QMS). Certified Lead Auditor in ISO 17025 and ISO 9001. Versed in ISO 31000, ISO 14001, and ISO 45001. Skilled in Laboratory Information Management System (LIMS), Document Control software, and Crystal Reports. Certified in Federal Records Management.
Overview
22
22
years of professional experience
11
11
Qualify Management System experience
13
13
Year of Molecular Biology experience
2
2
Certificates
Work History
Quality Assurance Specialist I-II
BNBI/NBACC
Frederick, MD
08.2012 - Current
- Continuous review and verification of lab's compliance to ISO 17025, ISO 9001, ISO 31000, ISO 14001, and ISO 45001. Perform 44+ internal audits, 4 supplier audits, lab Inspections, tracebacks of completed work, blinding of samples, quality review and release of material and reagents, review and proofing of reports and plans, provide training in quality-related topics, corrective action and preventative action (CAPA), root cause analysis, generate SOPs. Audited by external accrediting body 6 times with 3 no finding audits.
- Software: Quality point of contact for LIMS and document control software. Work with Application Support and lab staff to develop procedures and documentation within Forensics STARLIMS Equipment, Inventory, and Case Management modules, in compliance with ISO 17025. Produce, maintain, review, and approve competence testing for STARLIMS access. Work with Application Support and QA to develop procedures and documentation for supplier audits, lab inspection and traceback within EtQ Reliance. Create and maintain training, author and support validation scripts, review and authorize systems and updates.
- Federal Records Management: Assisted in implementing NBACC Records Management Policy.
Molecular Biology Technical Staff Supervisor
BNBI/NBACC
Frederick, MD
03.2011 - 08.2012
- Daily management and staff supervisor for NBFAC Molecular lab group.
- Performed Real-Time PCR, LRN, ABI 7900, and ABI 7500, equipment maintenance, reagent inventory, training, writing SOPs.
- Worked in BSL-2 and BSL-3 labs under ISO 17025 compliance.
Research Assistant III
BNBI/NBACC
Frederick, MD
10.2009 - 03.2011
- Skilled in Real-Time PCR, equipment maintenance, and reagent inventory.
- Laboratory Response Network (LRN),
- Worked in BSL-2 and BSL-3 labs under ISO 17025 compliance.
Research Associate IV & Lab Supervisor/Team Leader
Pathogen Functional Genomics Resource Center, J. Craig Venter Institute /The Institute for Genomic Research
Rockville, MD
10.2001 - 10.2009
- Managed PFGRC Microarray Production Group.
- Primary contact for 500+ investigators.
- Lab management duties.
- Assisted Directors with budget development.
- Lab skills include RNA/DNA isolation and purification, Real-Time PCR, construction of cDNA, genomic and BAC libraries, bacterial transformations, restriction endonuclease digestions, electrophoresis, southern and northern blots, pulse field electrophoresis, hybridizations with radioactivity, cloning and subcloning, tissue culture methodology, In vitro drug toxicity assays, cell line culturing.
Education
Bachelor of Science - Cell Biology
Shepherd University
Shepherdstown, WV 08.1985 - 1989.06
Skills
Quality Assurance: Maintain compliance with ISO 17025, ISO 9001, ISO 31000, ISO 14001, ISO 45001
undefinedAffiliations
American Society for Microbiology
American Society for Quality (ASQ)
American Association for Laboratory Accreditation (A2LA)
Certification
Federal Records Management
Timeline
Quality Assurance Specialist I-II
BNBI/NBACC
08.2012 - Current
Molecular Biology Technical Staff Supervisor
BNBI/NBACC
03.2011 - 08.2012
Research Assistant III
BNBI/NBACC
10.2009 - 03.2011
Research Associate IV & Lab Supervisor/Team Leader
Pathogen Functional Genomics Resource Center, J. Craig Venter Institute /The Institute for Genomic Research
10.2001 - 10.2009
Bachelor of Science - Cell Biology
Shepherd University
08.1985 - 1989.06
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