Quality Systems Manager Resume Example
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QUALITY SYSTEMS MANAGER
Summary
Motivated, resourceful, and dynamic pharmaceutical and medical device professional with comprehensive Quality Assurance (QA) manufacturing experience, proven management and leadership abilities, and a strong background in process and system development.
Thrives in fast-paced and highly regulated environments with an aptitude for quickly mastering new tasks, tools or technologies, process knowledge, and Current Good x Practice (CGxP) compliance.
Skilled in identification of compliance gaps and quality-related issues, utilizing resources and personnel as well as fearless approach to problem solving to quickly resolve issues and achieve improved output.
Areas of Expertise
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Professional Experience
Thermo Fisher Scientific Inc.Athens , GAQuality Systems Manager12/2015 to Current
- Served as back-up for Head of Quality.
- Interviewed, hired, coached and managed team of multi-level Quality Assurance professionals.
- Used experience and knowledge to help create a robust quality process for the startup of Oral Solid Dose (generic and controlled substances), Injectables, BFS and Nebulizer manufacturing facility.
- Instrumental role in site receiving DEA and NCHHS licenses for the manufacture of schedule 2 and 2n controlled substances.
- Site host for regulatory agency audits.
- Coordinated with colleagues all over the globe for successful technical transfer of products and ANDA application, ensuring quality at every stage.
- Reviewed and approved all raw material, packaging material and API testing for site.
- Built and managed team responsible for all site specifications, standard test procedures and certificates of analysis.
- Developed and managed Document Control system.
- Implemented ERP system for bar code tracking of all site documentation.
- Authored quality systems Standard Operating Procedures (SOPs).
- Reviewed and approved all site SOPs, Batch Production Records (BPR), policies and associated GMP documents (i.e. deviations, investigations, CAPAs).
- Project manager for selection, procurement and pending implementation of company's electronic quality system (MasterControl).
- Review and approval of validation protocols.
- Developed and managed site Training program, including on-boarding, for over 150 employees and contractors.
- Obtained multi-year training grant with capital investment of $19.3 million for site from State of North Carolina working in conjunction with local community colleges, NC BioNetwork and other state-funded training services to perform numerous trainings at no cost to site.
- Developed and managed Supplier Qualification program.
- Solely responsible for all supplier qualification and audits.
- Ensure that all materials and services purchased and received at the site are qualified and maintained through the quality system.
- Implemented, validated and managed SAP Quality Management program.
- Served as SAP Super User and SAP Administrator for the site.
- Supported daily plant operations in maintaining compliance and quality.
- Served as site representative for Quality on the safety committee.
- Collected, analyzed and reported performance metrics for Quality Systems.
Grifols Inc.Merrillville , INQuality Systems Supervisor08/2014 to Current
- Responsible for team of 10+ Quality Assurance Inspectors and Quality Assessment Technicians.
- Drafted action plans and led meetings with executives to review project status and proposed changes for a new lubricity option for the company.
- Responsible for maintaining controlled documents and updating as needed.
- Assisted in managing and securing ISO 13485 Manufacturing certification.
- Worked independently and as part of a team on CAPAs.
- Analyzed deviations which led to updating processes and implementing change orders.
- Worked as a team with Quality and Regulatory affairs to address customer complaints.
- Conducted 5S of cleanrooms and production areas.
- Developed and Managed: AssurX/CATSWeb Electronic Batch Record (DHR) System Device History Record (DHR); analyzed and reported trends during Quarterly Management Review (QMR).
- Material Review Board; worked closely with Senior Supplier Quality Engineer to communicate expectations for raw materials; performed supplier audits.
- Incoming, raw material and finished product inspection systems, including batch release criteria and sampling plans.
- Quality auditing program for real-time compliance assessment.
- Training and certification track for packaging personnel as a response to non-conformances in packaging.
- Batch release process; Responsible for preparing all batch review and release for company, including suggesting batch release testing and specifications.
Eaton CorporationSmyrna , GAQuality Systems Specialist and Inspection Team Lead12/2013 to 08/2014
- Responsible for managing, training and developing team of 4 Quality Inspectors.
- Developed manual visual inspection and inspector qualification system for parental drug products.
- Provided guidance to ensure that design control requirements were being met in an effective manner, including those for design verification, validation, specifications and procedure development, risk management, stability studies, and design review.
- Analyzed and interpreted complicated data sets.
- Participated in communications with suppliers to ensure requirements are understood and component/product performance is appropriately managed.
- Authored numerous procedures, work instructions, specifications, inspection forms and protocols.
- Assisted in writing validation and design space protocols and reports.
SiO2 Medical ProductsCity , STATEQuality Technician09/2013 to 12/2013
- Validated quality processes by establishing product specifications and quality attributes.
- Proactively identified opportunities for process improvements by measuring and monitoring quality and production including components, products, materials, packaging and equipment Generated and presented Quality Management Review report and metrics to monitor and evaluate effectiveness, compliance and relevance of Quality Systems by developing applicable tools and trackers; gathering and analyzing data for trending.
- Initiated several quality systems including incoming and in-process inspection.
- Reviewed, analyzed and documented data against specification.
- Monitored processes and production floors, suggesting improvements.
Education
Bachelor of Science:Biomedical SciencesAuburn University, City, State
Bachelor of Arts:SpanishAuburn University, City, State
CERTIFICATION, TRAINING AND MEMBERSHIP
Certifications:
- ASQ Certified Quality Technican (CQT)
- Six Sigma Yellow Belt
- Aseptic Processing I and II
- Elements of Current Good Manufacturing Practices (CGMP)
- Hazwoper 24-Hour
- OSHA10
- Powered Industrial Truck Trainer and Operator
- DOT Hazmat
- CPR
- Bloodborne Pathogens
Other Training:
- Effective Internal and External Quality Assurance Auditing for FDA Regulated Industry Seminar
- Design Verification and Process Validation
- Excel Spreadsheet Validation
- MiniTab Training (Beginner and Advanced)
- AssurX/CATSWeb Training
Professional Memberships:
- American Society of Quality (ASQ)
- Parenteral Drug Association (PDA)
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Resume Overview
School Attended
- Auburn University
Job Titles Held:
- Quality Systems Manager
- Quality Systems Supervisor
- Quality Systems Specialist and Inspection Team Lead
- Quality Technician
Degrees
- Bachelor of Science : Biomedical Sciences
Bachelor of Arts : Spanish
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