Well-qualified QA Specialist with a broad background in regulatory compliance, manufacturing, and research and development
Recruited and trained up an Internal Audit team
Mentored less experienced QA members as to the skills needed
Improved GLP compliance
Developed and presented well-received training in regulations, Quality Systems
Certificate, 3.5 GPA, voted Class Representative
Three years towards BA, Biology major
Provide QA support to Manufacturing and Laboratories (Micro and Chemistry), maintain and monitor Quality Systems, train employees in Regulations and Quality Systems. This support involves: Batch Record review, release of manufacturing suite and materials; review of test results and non-conformity reports, SOPs: review/approval of validation/ GLP protocols and reports; inspections and audits.
Provide screenings (bone density, diabetes, hypertension,etc) for the community. Educate on disease prevention and management. Market hospital's services. (This is a per diem, weekend seasonal position.)
Safely transport patients for procedures, admissions to units, or discharge. Represent hospital as a caring, patient-focused facility, providing excellent customer care to diverse population. (This is a per diem occasional weekend position.
Within a Contract Research Organization, monitored GMP studies and GLP studies for compliance to regulations, protocols and SOPs to ensure data integrity; developed and presented regulatory training; audited study data and reports; prepared written reports of findings; maintained Master Schedule; performed internal audits and vendor audits. Interfaced with clients during audits to address issues.
Within a major pharmaceutical company's Diagnostic Imaging Division, held positions within Manufacturing, QC (Microbiology and Chemistry), and R&D (Pilot Plant, Aseptic Manufacturing). Extensive knowledge of manufacturing equipment and processess, laboratory analysis and equipment. GMP documentation. Performed studies to develop, validate and support manufacturing process; validated equipment and utilities as part of a facility upgrade; produced material for toxicology studies and clinical studies, generating and reviewing batch records.
Annual Regulatory Training Presentations
"Initial On Board" GLP Training, Charles River Labs
"Focusing on GLPs", CRL
"Quality Matters: Bringing the Message Home", CRL
"History of the GXPs: Tragedy to Response", NERCSQA
NERCSQA (New England Regional Chapter of Society of Quality Assurance
Companies Worked For:
Job Titles Held: