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Rosalie A. Brown
8969 Autumngate Ln, Huber Heights, OH 45424
937-422-5143 rabrown8969@yahoo.com
Experience
AstraZeneca; formerly Amylin Ohio LLC, a wholly owned subsidiary of Bristol-Myers Squibb;
Quality Assurance Auditor; contract position through Astrix, West Chester, Ohio 2013-present
 Coordinate and conduct internal audits per audit schedule, to ensure US and Outside US
(OUS) regulatory compliance as applicable, including issuance of final report,
corresponding corrective actions, follow-up, and tracking ongoing activities.
 Conduct external audits as required.
 Perform various quality inspections and effectiveness reviews as required.
 Maintain master internal audit schedule and quality audit files for regulatory activities.
 Ensure quality systems meet applicable regulatory requirements.
 Interpret FDA and other OUS regulations including 21 CFR Parts 210 & 211, EudraLex,
Japanese GMPs, ICH, corporate policies, and procedures as applicable, with regards to
regulatory compliance.
 Perform data integrity review (DIR) of Annual Product Quality Review Report and other
GMP documents as required.
 Assist with the User Requirements Specification, preparation of test script, Acceptance
test and execution for Trackwise implementation.
 Knowledge of Microsoft applications, SAP, Trackwise and LIMS.
Battelle Biomedical Research Center
Quality Assurance Specialist 2008 - 2012
 Assure that programs are conducted in compliance with all applicable
regulations/standards: GLP, ISO, internal policies and quality assurance plans of
government agencies.
 Served as a lead auditor on multiple studies, providing compliance advice and support.
 Audit data and study files assuring GLP compliance and consistency.
 Assist with data, investigation reports (IR), validation packages, protocols, final reports,
SOP and various document review for accuracy.
 Issue corrective action requests (CAQ), register deviation reports (DR), and calibration
status notifications (CSN).
 Gather supporting documentation as necessary.
 Perform critical phase inspections, monitoring for appropriate regulatory/guidance,
protocol, and SOP compliance.
 Perform internal facility inspections of laboratory and supporting areas and BL-3
laboratories.
 Update QAU files, databases and indices as required. Notify management of major findings
and resolve as appropriate.
 Knowledge of 21 CFR Parts 11, 58, 820, 314.610 & 601.90 (Animal Efficacy Rule for
Drugs & Biologics) and ISO 9001:2008.
Pharmaforce Inc.
Microbiologist 2007 - 2008
 Microbiological in-process, raw material, and finished product testing including sterility,
LAL, growth promotion, plate reading, microbial identifications, water testing and closed
container testing.
 Validations of microbial enumeration tests.

2. Rosalie A. Brown
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 Execution of laboratory Out-of-Specification (OOS) investigations.
 Reviewed and prepared new and/or revised Standard Operating Procedures (SOPs).
 Trend analysis.
 Gowning and performing environmental monitoring in GMP class 100 to 100,000 facility.
Knowledge of 21 CFR Parts 210, 211.
Belmonte Park Laboratories (nonextant) Dayton, Ohio
Microbiologist / Technical Consultant 2000 - 2007
Environmental Technician 1999 - 2000
 Administrative functions include management of A/R and A/P accounts and payroll.
Handled client relationship management function and cultivated positive and enduring
relationships with clients.
 Generated new business through presentation of laboratory products to clients, and follow-
up.
 Familiar with HAACP, GLP and cGMP guidelines. Microbiological analysis of water,
food, raw materials and cosmetics, including: bioburden, sterility testing, shelf life studies,
Listeria, Ecoli, Ecoli H 0157, coliform, total coliform, fecals, Salmonella, Staph,
Pseudomonas, total plate counts, yeast and mold counts, according to USP, CTFA, FDA,
USDA, BAM, AOAC, ASTM or Standard Methods For The Examination Of Water &
Wastewater guidelines.
 Sample analysis by direct microscopic examination techniques. Performed isolate
identifications.
 Ensured maintenance and calibration of microbiology laboratory equipment. Maintained
microbial stock cultures.
 Performed preservative efficacy evaluations.
 Performed field collection of samples, following EPA regulations concerning sampling
protocols.
 Maintained sampling schedules for clients according to NPDES or other permits.
Education
Columbia Southern University Orange Beach, Alabama
M.S. Occupational Safety and Health with Environmental Mgmt. Concentration 2014
The Ohio State University Columbus, Ohio
B.S. Microbiology 1994
Case Western University Cleveland, Ohio
Summer fellowship 1990
Responsibilities included Ames testing utilizing Salmonella Typhimurium. Conducted research
concerning the effects of glutathione on microbial transport systems.
Certifications
State of Ohio EPA, Certified Drinking Water Analyst
Memberships
Society of Quality Assurance 2010
Midwest Regional Chapter of the Society of Quality Assurance 2011