Management and training: eight years supervision, hiring, training oversight, and staff development; process management. Fifteen years of experience in FDA/Government Regulated industry: nine years in Quality roles, four years in Management roles
Cofidential, Quality Supervisor
Raleigh, NC 08/2008-Present
Maintains company’s system for documenting, investigating nonconformities, and evaluating efficacy of corrective actions. Determines root cause analysis and implemented corrective action (CAPA) plans. Manages lookbacks, post-donation investigations, and Unsuitable Test Results. Manages and maintains deviation tracking, error tracking, and collections exceptions. Reviews, tracks and analyzes data for product stability programs. Documents trends and tracks medical incident reports, equipment malfunctions, and employee training records. Ensures that internal and external audits are completed as per required schedule. Per procedure, reviews the release of all cGMP materials. Ensures compliance with safety, quality, regulatory and budget requirements. Reviews and approves all documents impacting quality assurance such as specifications, stability programs, protocols/reports, SOPs, validation and qualifications programs. Addresses OOS, OOL, and equipment issues. Reviews and documents IQ/PQ/OQ validations for equipment. Successfully prepared facilities for regulatory submissions to CLIA, FDA, and GHA.
Cofidential, Lead Quality Specialist
Charlotte, NC 09/2003-08/2008
Responsiblefor reviewing, approving, and monitoring the systems and processes specified in the Q & RA SOP’s; and/or critical control points as specified in operational documentation. Effectively communicated concerns identified in the manufacturing or testing process to quality assurance and operations management staff. Ensured that compromised product or test results are not released or to immediately implement recall or market withdrawal processes if deemed necessary. Presented quality assurance meetings on an on-going basis. Maintained established government, safety, and OSHA standards. Worked closely with Director and Operations Manager in preparing for, hosting and closing out ARC, FDA, AABB, ARC, CLIA or other inspections/audits as necessary. Ensured the implementation and effectiveness of corrective actions, meeting all standards and product Quality. Made suggestions for improving procedures. Responsible for training staff in the areas of manufacturing process, testing, quality issues, troubleshooting, equipment operations, and timely delivery. Serve as an effective motivator for the staff within the department.
Cofidential, Technologies Chemist
Performed wet chemistry analysis, gas chromatography, operated the Atomic Absorption Spectrophotometer, Inductively Coupled Plasma Emission Spectrometer, and Spark Optical Emission Spectrometer. Performed preventative maintenance on all instruments in the laboratory, troubleshooting and problem solving skills, Laboratory Information Management Systems, Microsoft Word and Microsoft Excel, executed method validation, reviewed procedures for audits and assisted with writing procedures for new test and assays, performed comparison studies and data analysis. Trained new employees on procedures and policies
Bachelors of Science