Quality Assurance Staff

Quality Assurance Staff Biographies  

, Director, Quality Assurance Services

Pat directs the staff of the Quality Assurance Services department and is an active auditor.  He coordinates auditor activities and schedules, negotiates and prepares budgets, interprets regulations and tracks regulatory initiatives, and develops and reviews departmental SOPs.  Since joining BSI in 1994, he has performed facility inspections of vendor, CRO, sponsor, and clinical investigator sites; mock regulatory inspections of sponsor sites; audits of data and reports for bioanalytical method validations and analyses; audits of human and veterinary clinical study documentation and reports; performed study site and phase inspections; developed audit methods; performed QC reviews of research studies; reviewed regulatory submissions; and performed database audits.  Pat has presented at national and global meetings of the Society of Quality Assurance.  He has more than 20 years of experience as an analytical chemistry laboratory supervisor, research associate, instructor, and technician.  He holds a B.A. in biology; has completed postgraduate work in biochemistry, physical chemistry, and mathematics; and has been a Registered Quality Assurance Professional in Good Laboratory Practice since 1997 and in Good Clinical Practice since 2009.

, Senior Quality Assurance Auditor

Barbara, an employee of BSI since 1987, joined the Quality Assurance Services department in 1992. In her career as an auditor, she has assessed procedures and processes; developed SOPs, data collection forms, and policies; audited vendors and CROs; inspected laboratories, toxicology facilities, clinical investigator sites, clinical monitoring and database CROs; and audited all types of data and reports. She provides quality assurance and quality control services for research discovery studies, safety studies, animal clinical trials, bioanalytical method validations and analyses, and human clinical trials. Barbara has presented training sessions at national meetings of the Society of Quality Assurance (SQA) and the College of American Toxicologists (ACT).  She has served on the SQA Education Committee and the Council for Professional Registration. Prior to joining BSI, she worked as a registered clinical laboratory technologist in immunohematology, hematology, cytogenetics, radioimmunoassay, and chemistry laboratories. Barbara holds an MBA and an undergraduate degree in genetics and is both a registered quality assurance professional (RQAP-GLP) and a registered medical technologist (ASCP-MT).

Melissa is a Senior Quality Assurance Auditor at BSI. As an auditor, she has participated in Human and Veterinary GCP and GLP audits of raw data and reports, led GLP facility inspections, conducted IND Research Report QC reviews, audited analytical and bioanalytical data and reports. She provides quality assurance services for safety studies, animal clinical trials, and analytical method validations. As BSI’s QA Archivist, she maintains the project and archive files, ensuring that electronic and paper files are consistent and correct. She assists with developing and reviewing departmental practices and standard operating procedures. Melissa became a Registered Quality Assurance Professional in Good Laboratory Practice (RQAP-GLP) in October 2009. Prior to joining Biotechnical Services, Inc. in 2007, Melissa worked in the Higher Education Industry. She holds a Bachelor of Arts in Chemistry and English and a Master of Science in Education in Counseling: Higher Education Student Services.

, Quality Assurance Auditor

Jason joined the Quality Assurance Services staff as an Auditor in 2008 and has participated in Human and Veterinary GCP and GLP audits of raw data and reports and GCP facility inspections. He has also performed audits of analytical and bioanalytical data and reports. He holds a B.S. in Biochemistry and has over 10 years of hands-on, research laboratory experience, working in molecular biology, genotyping, and immunology. Jason also has extensive training and experience with Biacore instrumentation and is co-author of research articles published in various peer-reviewed, scientific journals, such as the Journal of Biological Chemistry. Jason became a Registered Quality Assurance Professional in Good Laboratory Practice (RQAP-GLP) in November 2011.

, Quality Assurance Auditor

Sherry is our newest Auditor on the Quality Assurance Services staff joining in May 2011.  She performs data and report audits in support of the development and marketing of pharmaceutical, agricultural, and chemical products.   Sherry has a Master of Science in Biology with Ecology and Botany emphasis.  Her experience includes farming, teaching college laboratory classes and as a Biological teacher in Secondary Education, Advanced Placement Biology, Ecology and Microbiology.  Sherry is a published researcher co-authoring scientific articles in peer-reviewed ecological/environmental journals such as the American Midland Naturalist.

Presentations and Posters Presented by BSI Quality Assurance Staff

Clinical Laboratory Inspections: Know What to Look For. , B. B. Randolph (2011). Presentation at Society of Quality Assurance (SQA) Annual Meeting, San Antonio, TX. .

Checklists and Templates: Facility Audit Help or Hindrance. , B. B. Randolph M. M. Hughes and J. R. Plaxco (2010). Poster presented at Society of Quality Assurance (SQA) Annual Meeting, Cincinnati, OH.

Quality Assurance in Multi-Site Studies. , P. H. Carver, B. B. Randolph M. M. Hughes and J. R. Plaxco (2009). Poster presented at Society of Quality Assurance (SQA) Annual Meeting, San Diego, CA.

Departmentalization Coordination: A Team Approach. B. Randolph, P. H. Carver, and M. Hughes (2008). Poster presented at Society of Quality Assurance (SQA) Annual Meeting, Memphis, TN.

Overview and History of the GLPs, the Study Director’s Role, and the FDA Inspection. B. Randolph (2007). Presented at the Annual Meeting of the American College of Toxicology, Charlotte, NC.

GLPs in the University Environment - Comparison of the Industry/University Views. P.H. Carver, J.M. Fowler, D.K. Carver, R.C. Anderson, and C. Hamon (2007). Presented at Society of Quality Assurance (SQA) Annual Meeting, Austin, TX.

Overview and History of the GLPs and the Study Director’s Role. B. Randolph (2006). Presented at the Annual Meeting of the American College of Toxicology, Indian Wells, CA.

Computer-Based Tools for the QA Auditor. B. Randolph. (2006). Poster presented at Society of Quality Assurance (SQA) Annual Meeting, Phoenix, AZ.

Initiation of Contract Analytical and Bioanalytical Laboratory Analysis Projects:  Quality Beginnings Facilitate Quality Outcomes. P. H. Carver (2005). Presented at Society of Quality Assurance (SQA) Annual Meeting, Orlando, FL.

Practical Tips for Auditing Analytical Chemistry Data. B. Randolph (2003). Presented at Spring Training, Society of Quality Assurance, Seattle, WA.

Regulatory Document Review and Source Documentation Review. B. Randolph (2003). Presented at Spring Training, Society of Quality Assurance, Seattle, WA.

Regulatory Document Review. B. Randolph (2002). Presented at Basic GCP Training, Society of Quality Assurance Annual Pre-Conference Training, Albuquerque, NM.

Entertaining Training: Self-Directed PC Training Modules for QA Professionals. B. Randolph (2001). Poster presented at Society of Quality Assurance (SQA) Annual Meeting, San Diego, CA.

A QAU Fitness Program. B. Randolph (2000). Presented at Society of Quality Assurance (SQA) pre-conference training, Establishing a QAU for your Organization, Montreal, Quebec, Canada.

Auditing Analytical Reports and Data. B. Randolph (1999). Presented at SQA pre-conference advanced session, Auditing Reports and Data, Chicago, IL.

Analytical Facility Inspections. B. Randolph (1999). Presented at SQA workshop, Analytical Chemistry for the QA Professional, Reno, NV.

Auditing Analytical Data. B. Randolph (1999). Presented at SQA workshop, Analytical Chemistry for the QA Professional, Reno, NV.

Clinical Pathology Inspections and Data Audits. B. Randolph (1998). Presented at SQA workshop, GLPs and GCPs in Target Animal Studies, Reno, NV.

Analytical Data Audits. P. H. Carver (1998). Presented at Society of Quality Assurance (SQA) Annual Meeting, Reno, NV.

Check-off logs for routine equipment maintenance match records with SOPs. B. Randolph, P. H. Carver, and M. A. Brewster (1995). Poster presented at Society of Quality Assurance (SQA) Annual Meeting, Phoenix, AZ.

Quality Auditing of Chromatographic Data. F. M. Pattillo, P. H. Carver, and M. A. Brewster (1995). presented at Society of Quality Assurance (SQA) Annual Meeting, Phoenix, AZ.

“InFORMTM: A Utility Subsystem for Achieving Automation in Technical Reporting”. Corley GF, Dennis PR, Randolph BB, Hirrel MC. (1991) Symposium on Applied Computing, Institute of Electrical and Electronics Engineers, Inc.: 238-245.