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Click here or scroll down to respond to this candidateCandidate's Name
PHONE NUMBER AVAILABLE EMAIL AVAILABLE LINKEDIN LINK AVAILABLEExperienced Quality Auditor with greater than 20 years of experience in QA/QC, Regulatory Compliance, implementing Quality standards, Auditor roles for food, sterile injections, solid oral dose and medical/OTC repackaging industries; experienced in manufacturing & laboratory environments; training staff, Change Management, assuring compliance with cGMPs & applicable regulations, FDA 21 CFR (Parts 210, 211, 522 and 820). Creating & implementing CAPA Systems; as well as developing, reviewing, writing, revising and approving SOPs, work (job) instructions, MBRs, specifications and other quality documents. Hosted customer, regulatory (FDA & DEA) and certification audits. Lead the activities associated with remediation actions if needed because of the site audit findings. Conducting vendor, supplier, and hosting customer onsite audits.KEY COMPETENCIESManufacturing Experience, Quality Management System (QMS); Document Control Performed Internal Audits/Third-Party Audits, Regulatory Inspections Data analysis Strategic Leadership Training staff Writing deviations/CAPAs Strong Organizational skills Problem-Solving Coaching, Listening & Interpersonal skills Continuous Improvements Detail-oriented Critical thinking Deductive reasoning, & decision-making skills, based on data analysis Leader in compliance/regulation assessment and trainingPROFESSIONAL EXPERIENCENATURES ONE, Inc Heath, OHSr. Batch Record Auditor/CAPA Specialist Sept 2022 - May 2023Batch record review (auditing) & revise all records adhering to GMP regulations. Review of all testing prior to release. Duties included batch record review, authoring SOPs & WIs and training. Review and approval of all deviations, CAPAs & disposition of raw materials. Wrote monthly reports on metrics (KPIs) based on data collection for senior management.Wrote SOPs and updated existing SOPs in the Quality system library (Production system, Facility & lab equipment system, Laboratory Control system, Materials system and Packaging and Labeling System). Provided organization structure to QA and production.Compliant to OJT and cgmp training programs and documentation.NOVAVAX, Inc Gaithersburg, MDQuality Specialist IV-Remote Feb 2021- Aug 2022Review of analytical records and data collection during the manufacturing and/or testing of vaccines (sterile injectables) for compliance. Review of records and data include but not limited to: TT (Tech Transfer-biotechnology), disposition of Batch Records, data collection for Clinical Immunology records.Developed solutions to a variety of problems of moderate scope and complexity.Knowledge and experience with cGMP, US FDA and basic knowledge of EU GMPs.A solid understanding of the analytical chemistry and microbiological test methods which are pharmaceutical regulated industry.BOCCHI LABORATORIES, -Facility Closed New Albany, OHQuality Document Specialist/ Document Control June 2020 Feb 2021Designed, created, and maintained the Quality Management System for the manufacturing facility in manufacture of OTC (over the counter) and beauty production.Training & development for all 3 shifts to be aligned on company goals (teamwork amongst all shifts) and creating a cohesive regulated environment.Ensure products are manufactured in a manner consistent with applicable cGMPs and meet all relevant quality standards.INGELHEIM DISTRIBUTION (BI), Columbus, OHQuality Specialist IV March 2019 - June 2020Independently perform batch record review and/or final disposition of drug products manufactured by Contract Manufacturer Organizations (CMO) and BI Operation entities, assuring accuracy of production records. Maintaining records from different site operations. Identifying quality improvement opportunities for the business such as shortening TAT for review of records.Knowledge and experience with cGMP, US FDA and basic knowledge of EU GMPs.AMERICAN HEALTH PACKAGING, Columbus, OHManager, Sr. Quality Assurance May 2016 - April 2018Managed & supervising Quality Assurance operations across all shifts and maintained 24-hour availability, overseeing 20 staff, including 5 direct reports. Oversight of QA Ops personnel. Reported monthly performance metrics (as well as recommendations for improvement as well as continuous improvement to increase productivity) to senior management and assisted in budget planning. Provided quality products (pharmaceutical including OTC, scheduled controlled drug classes, (Class 1 medical devices) to consumers.Approved IQ, OQ and PQ on packaging equipment for the lines used for commercial products.Created a process and trained selected employees (collaborative relationship with production) for CS repackaging, to avoid any diversion of controlled substances.Hiring, onboarding, initial and ongoing training & development, performance management, and succession planning for all floor operations.Continuous on-going training for all 3 shifts.CARDINAL HEALTH, - Facility Closed Zanesville, OHManager, Quality Assurance & Regulatory Compliance Oct 2014 - May 2016Leading the overall quality system and compliance program for all aspects related to on-site repackaging of pharmaceutical products, and dietary supplements. Provided training for DEA controlled substance requirements Class 1-3.Conducted multiple mock audits to be site ready for FDA and DEA with all employees.Afterwards, passing all FDA and DEA for site inspection with no findings.Provided strategic leadership to organizational structure and ensuring the organization provided proactive and strategically align talent life-cycle management for new hires.PHARMAFORCE, INC., Hilliard, OHSupervisor, Quality Assurance Batch Records/ Operations Sept 2010 - June 2014Managed 11 Quality Assurance personnel, this included record review and operations staff across multiple areas, while overseeing QA/QC activities as well as providing support to all other departments including production, facilities/engineering, QC, and incoming materials management. Developed three shift schedules for QA Ops teams.Developed metrics for first time right & weekly communication meeting with QA & Ops. Trained all employees on safety guidelines. Process excellence.Reviewed, revised and approved controlled documents/(EBRs), Standard Operating Procedures, and protocols. Acts as a representative on cross-functional teams that require batch disposition input. Wrote and updated test methods for QC group.Completed all investigation and resolved deviations that impact batch prior to disposition.A solid understanding of the analytical chemistry and microbiological test methods which are typical within the dietary supplement, pharmaceutical, food, or a similarly regulated industry.ABBOTT LABORATORIES, (ISO 9001) Columbus, OHSenior, Documents Coordinator Plant Quality Systems April - Nov 2005Led internal projects applying GFSI standards for infant formulations and medical nutritional products.Document Coordinator Quality Systems May 2002 - April 2005Administered, audited, reviewed, and maintained controlled documents, plant procedures, IOPs, job aids and wrote Quality Control procedures.Assistant Chemist II, Quality Assurance / Quality Control Laboratory March 1996 - May 2002Analytical chemistry / laboratory operations testing of raw material ingredients, in-process batches, and finished products. R & D product development testing. Calculated statistical analysis charts based on testing of finished products.EDUCATIONBachelor of Science (BS) MicrobiologyThe Ohio State University, Columbus, OHCERTIFICATION, TRAINING and PROFESSIONAL MEMBERSHIPSAmerican Society of Quality (ASQ) Member (since 2010); Certified Quality Auditor (CQA), 2018ASQ - Columbus Chapter - SecretaryFDA Thermal Processing (Low Acid Food School) in Food Science Dept., The Ohio State University, 1999Flavor, Aroma and Grain Training, Laboratory Safety Guidelines & Training 1996-2002 (annually) |
