Dedicated Sr. Quality Systems Specialist experienced in Quality System Nonconformance management . In-depth knowledge of FDA tissue, medical device and biological drug regulations.
Motivated and results-driven Operations Analyst with a proven track record in data analytics and process optimization. Proven ability to identify business needs and develop valuable solutions to drive accuracy and process efficiency. Seeking an opportunity to drive business effectiveness through making recommendations based on data findings. Operations Research Analyst with [number] years of experience delivering innovative breakthroughs by applying statistical, mathematical, and analytical methods to process optimization. A collaborative team player with the ability to manage expectations from multiple, diverse stakeholders. Excellent decision-making skills with sound judgment to recommend best practices for complex data analyses. Systems Analyst with an analytical mindset and natural problem solving abilities. Customer-focused with excellent communication skills to gather requirements, perform business analytics, and deliver cutting-edge solutions. Seeking a role that incorporates technical and leadership skill sets to drive business productivity and performance. A technical subject matter expert in system analysis, validation, and support. Proven expertise in understanding specifications and standards to successfully deliver projects in a timely, cost-effective manner. Detail-oriented professional with extensive system administration scripting experience using Perl, Bash and KSH shell programming technologies. Focused Sr. Quality System Specialist versed in ISO, FDA, regulations and process improvement. Applies in-depth knowledge of quality trends and shifts to offer valuable insights on opportunities for process and product improvements.
Dedicated Sr. Quality Systems Specialist and effective leader who excels at using proven methods and cutting-edge technology to successfully cut costs, streamline operations and increase productivity.
03/2013 to Current
Sr. Quality System SpecialistCompany Name － City, State
Managed, developed, designed, and implemented an electronic NC and CAPA system Analyze Quality data to identify statistically significant trends within the NC system to determine when escalation to a CAPA is applicable
Maintain Quality system compliance to 21 CFR 820, AATB (Tissue Banking), ISO 9001 and ISO 13485
Review and Approve NCs and CAPAs for process deviations and nonconforming product associated to products regulated under FDA 21 CFR 1271: Human Cells, Tissue and Cellular based products, FDA 21 CFR 800: Medical Device, FDA 21 CFR 600: Biological Products and other global regulatory bodies including ISO, Health Canada, European Commission, and Australian TGA
Collaborate and interact with all levels of management in all departments to reduce nonconformance's and improve quality throughout the company
Maintain and Analyze Statistical Process Control Charts through Minitab software to identify process trends
Assist in Regulatory (FDA, ISO), Customer, and Internal Audits
03/2011 to 03/2013
Skin Processing Trainer/Fresh Graft Technician II/Process Subject Matter ExpertCompany Name － City, State
Present investigational Nonconformance findings to Quality Systems Manager and recommend corrective actions to improve process efficiency, reliability, to reduce errors
Designed a new production record format that reduced GDP errors that reduced scrap rates by (add % of gdp error NC reductions).
Received the ACE award in November 2012 for outstanding Quality
Trained and supervised technicians to procedures and best practices to maintain the lowest number of customer complaints on my shift for 2012
Processed fresh Human Skin for transplantation in accordance with Good Tissue Practices, Standard Operating Procedures, Work Instructions and Product Specifications.
10/2008 to 01/2011
Lead Bioreagent FormulatorCompany Name － City, State
Identified high risk production process steps through a Failure Mode Effect Analysis (FMEA)
Created and implemented a new extensive training program for the BioReagent Production Department based on the results of the process FMEA, and other historical quality data
Performed all work in compliance with FDA/cGMP regulatory quality standards Optimize and develop processes to increase efficiency and reduce errors
Maintained Process Control Charts and notified Quality Manager of any trends to prevent product from drifting away from the target control specification
Implemented corrective and preventative actions (CAPA) to reduce scrap rates due to processing errors
Guide FDA and external auditors through manufacturing lab Successfully reduced the annual formulation scrap rates from 12% to 1.49%, saving the company over $150.000 a year.
11/2005 to 10/2008
Research Associate ICompany Name － City, State
Aided in the development clinical molecular biology (PCR) in vitro diagnostic device products
Designed and performed research studies for infectious disease diagnostics product development
Wrote, developed, and revised Standard Operating Procedures (SOPs) for manufacturing of new medical devices, and associated quality control product testing
Extensively trained in Clean Room and Biosafety Level 2 practices and standards
Presented developmental statistical data and research findings to Directors and Scientists in quarterly lab meetings
Traveled to U.S. military bases to train Chemical Biological Medical Systems Joint Project Management Office personnel on the process for using a new magnetic bead based nucleic acid extraction, purification, and detection diagnostic device product for post design pre 510 (k) submission.
Bachelor of Science: BiologyMetropolitan State University of Dever － City, State
Associate of Science: BiotechnologySalt Lake Community College － City, State
June 6, 2015
Certified Tissue Bank Specialist (CTBS) Certification Date: September 8, 2012 Certification Number: 912023 Certification Status: Active American Society for Quality, Milwaukee, Wisconsin Certified Quality Process Analyst (CQPA) American Association of Tissue Banks － City, State
December 5, 2015
American Society for Quality, Milwaukee, Wisconsin Certified Quality Auditor (CQA)
Certification Status: Active
Analyst, Biotechnology, Charts, DNA, infectious disease, Internal Audits, ISO, ISO 9001, meetings, Office, Minitab, molecular biology, NCs, PCR, personnel, Process Control, processes, Quality, research, Statistical Process Control, technician
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Bachelor of Science : Biology Associate of Science : Biotechnology Certified Tissue Bank Specialist (CTBS) Certification Date: September 8, 2012 Certification Number: 912023 Certification Status: Active American Society for Quality, Milwaukee, Wisconsin Certified Quality Process Analyst (CQPA) Active
American Society for Quality, Milwaukee, Wisconsin Certified Quality Auditor (CQA) 64803
Certification Status: Active
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