Experienced GLP research quality assurance auditor with 14 years' experience in the biopharmaceutical field and skilled in various areas of current QA methodologies. Meticulously detail-oriented and organized with expertise in analysis, inspection, and equipment functionality.
• Assured that nonclinical study data and bioanalytical clinical study data collected in support of products regulated by FDA comply with the appropriate GLP regulations, protocol, and MedImmune SOP's.
• Performed in-process inspections of study phases, audits of raw data and final reports, and audits of internal facilities; summarize audit findings in written report format, and submit findings to principal investigator, study director and management; establish and maintain QA files and records.
• Performed initial and periodic vendor audits and assessments including policies, procedures, gaps from GLP regulations (FDA, MHLW and OECD), and perform in-process and raw data inspections of studies contracted to vendors.
• Performed review of controlled documentation for supported groups. • Participated in the development, implementation and maintenance of GLP compliance systems and training programs.
• Supervisory duties included overseeing the QA consultants used at the CA sties (Two locations at the time, Hayward and Mountain View)
• Provided QA support to all PDL departments and facilities that were involved in animal safety studies, data generation and analyses, other activities under FDA Good Laboratory Practice regulations and guidelines.
• Planned, conducted, and reported GLP inspections and audits of external vendors, internal PDL facility &systems, and study reports and documents.
• Liaison with PDL Departments and Quality Systems functions to support consistent GLP practices and advice.
• Developed, delivered, and documented comprehensive GLP training programs to PDL personnel that supported GLP activities and provided external training, as needed.
• Represented GLP QA on appropriate PDL teams to facilitate audit planning and timely GLP advice.
• Assisted in regulatory inspections of PDL facilities, as needed.
• Kept GLP Management apprised of compliance and personnel issues through periodic reports.
• Maintained good working relationships and communication with GLP QA customers. Provided supervision, training and guidance to junior GLP QA Staff as directed by GLP Management.
• Implemented independent assessments of protocols, laboratory procedures, data, facilities, and reports, to determine the level of compliance with applicable domestic and foreign Good Laboratory Practice Regulations (GLPs), Standard Operating Procedures (SOPs) and study protocols.
• Prepared accurate, concise, and clearly written reports of actual and perceived deviations from GLPs, SOPs, and protocols for submission to Study Directors and Management for corrective actions and review.
• Independently was responsible for all assigned studies including:
• attendance at all study meetings
• determining the necessary phases to be inspected
• assuring required inspections are performed
• preparing reports of inspections
• maintaining accurate records
• maintaining the Master Schedule
• Provided peer training on various topics concerning lab inspections and procedures.
• Trained and developed QA Auditors.
• I helped a new department (Experiential Therapeutics become GLP compliant. • As a senior auditor, I was given one of our most preferred clients to always audit first over any auditor.
• As a senior auditor, I was given one of our most preferred clients to always audit first over any auditor.
•Facilitated test material administration including data collection •Observed and assessed student performance and kept thorough records of progress. (observations, measurement of body weight, and food consumption)animal husbandry, and data review.
• Acted as Lead Technician of various studies.
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