Accomplished Senior Quality Assurance Specialist with broad expertise in laboratory operations, training, and quality from clinical, government, and pharmaceutical research, training, quality control, quality assurance and management experiences.
Technical Skills: CAPA identification, processing, review, resolution; OOS investigation; Data Review; Report Review; SOP/Protocol Review and Management; In-phase inspections; Internal Audits; External audit support; Word, Excel, PowerPoint; Data Review; SOP/Protocol Review and Management; Data Review; SOP/Protocol Review and Management; Software Qualification; BioPlex; Mesoscale; Synergy; ELISA; RIA; TECAN operation and programming; Equipment qualification, operation, and maintenance; Experiment and Notebook documentation; Reagent preparation; Ordering and Procurement; PCR; Western Blotting; Fluorescence Imaging; Microscopy; Cell Culture; MicroArray
Soft Skills: Communication, Patience, Dedication, Team Building, Mentoring, Presentation Design, Public speaking, Listening, Delegation, Strategic Planning, Dispute/Conflict Resolution, Decision Making, Supervising, Managing, Collaborating, Negotiating, Motivating, Dealing with Difficult People, Resilience, Adaptable, Assertive, Empathetic, Problem Solving, Trouble-shooting, Planning, Scheduling, Time Management, Intercultural Competence, Training, Process Improvement
with trainer responsibilities my primary duties were to support the group by reviewing data from Sample Analysis and Validation studies and reviewed the reports that were the end product of those studies.
I also completed inspections of critical phases for non-clinical GLP studies (study start-up, sample check-in, assay setup, data review, and report review).
Other responsibilities involved reviewing deviations and SOPs and assisting in preparation for external audits.
Worked closely with the QA Manager to help analyze and resolve or assist personnel in solving quality-related problems and continued to participate in special projects.
Training responsibilities were maintained as with the QC position.
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