Sector Experience

Healthcare
Life Sciences & Pharma
39
years

Years of Experience

6/20

Member Since


Experience

 
Clinical Quality Assurance Services Management Consulting
Quality Assurance & GCP Consultant
01/2011 - Present
Provides a broad range of quality assurance auditing and consulting services to sponsor companies in the pharmaceutical and biotech industry.

Biovail Technologies Other
Manager, Clinical Quality Assurance
02/2002 - 12/2010
Provided management and coordination of clinical quality assurance activities with respect to GCP regulations and guidelines, including: routine and for cause investigator site audits, vendor selection process and audits, investigator meeting presentations, internal gaps analysis and assessment, hosted regulatory agency inspections, SOP development and maintenance, document review, departmental budgetary oversight, development of audit plans and interdepartmental GCP training.

Parexel International Other
Senior Quality Assurance Auditor
05/1998 - 01/2002
Performed contracted Quality Assurance services/consultations to the pharmaceutical and medical/academic industries pertaining to clinical and nonclinical site and systems audits to assure compliance with FDA and international regulations and guidelines.

Otsuka Pharmaceutical Other
Quality Assurance Auditor
08/1995 - 05/1998
Audited clinical investigators, CRO's, and laboratories to assure compliance with applicable Federal regulations and guidelines and study protocol requirements. Conducted audits of final data listings, final study reports, and clinical selections of NDA's. Performed internal systems audits to assure compliance with Federal regulations and corporate SOP's. Assisted in GCP training of Quality Assurance Associates and Clinical Research Associates; hosted regulatory agency inspections.

Hazelton Laboratories Other
Quality Assurance Technician
01/1986 - 09/1996
Inspected in-life phases of ongoing regulated studies to ensure that data was in compliance with applicable SOPs, protocol and GLPs.

American Red Cross Other
Quality Assurance Specialist
07/1994 - 07/1995
Reviewed, assessed and audited records, processes and systems critical control points, which included cessation of work, SOPs, training, competency evaluation and proficiency testing, equipment maintenance and calibration, change control, validation of software, equipment, and processes, error and accidents, complaints, adverse reactions, recalls, records management and document control; created and implemented corrective action plans.

Corning Hazelton Washington Other
Senior GLP Auditor
02/1987 - 07/1994
Inspected in-life phases of on-going regulated studies and reviewed final reports and related data for compliance with appropriate GLPs, protocols, and departmental SOPs, hosted QA-related sponsor visits, trained new auditors, scheduled all in-life inspections and final report reviews to be conducted, implemented automated auditing techniques for use with a local area network (LAN); tabulated actual monthly study completions, conducted departmental audits.

Hazelton Laboratories Other
Quality Assurance Specialist
09/1986 - 02/1987
In-Life group leader. Assigned QA staff to study pre-initiation meetings, and scheduled and assigned the inspections of on-going regulated studies. Conducted training of new In-Life auditors, maintained the Master Study Schedule for chronic and sub-chronic studies and hosted QA-related sponsor visits.

Hazelton Laboratories Other
Quality Assurance Technician
01/1986 - 09/1986
Inspected in-life phases of ongoing regulated studies to ensure that data was in compliance with applicable SOPs, protocol and GLPs.