SUMMARY:

• Skilled Quality Control Technologist with 10+ years of experience resolving quality control issues in a pharmaceutical manufacturing environment
• Effectively researches and diagnoses product performance issues relating to approved QC Standard Operating Procedures in compliance with FDA, GMP/QSR and ISO regulations
• Experience in technical R&D, validation studies and in - process testing of non-conforming elements
• Experience with technical troubleshooting, resolving semi-complex technical problems, and root cause analysis affecting daily operations to a development environment
• Performed testing and prepared reports as required for investigations of non-conforming material, performance evaluations, QC Audits and special projects
• Available to interview any day over the next two weeks, preferably before 3:00 pm
• Seeking full-time opportunities with consistent hours and opportunities for growth- extremely excited to be considered by Roche Molecular

PROFESSIONAL EXPERIENCE:

Confidential

Assistant Line Leader

• Collaborate with ID-Micro Typing System and BioVue Manufacturing Teams towards optimizing quality, lean efficiency and maximizing volume
• Received 2017 Golden Award for Quality Assurance
• Effectively research and complete investigations pertaining to batch record reviews, in-process testing, reagent bulk withdrawal, automation and compliance
• Manage material handling and reagent storage and disposal in coordination with QA teams
• Effectively manage process improvements (Lean Sigma 5S implementation)
• Proficient in SAP, GMP/ ISO and FDA regulations
• Special Projects included collaborating in creating and authoring departmental employee training manual

Confidential

QC Technologist II

• Researched and resolved non-conforming and performance issues with Technical Services, QA, Manufacturing, Research and Development (R&D), Clinical Affairs and Marketing
• Responsible for the execution of a broad range of bench test procedures used in raw material qualification, testing finished goods prior to release, investigation of product performance for routine validation studies, and assisting with timely product release/routine maintenance of Quality standards
• Performed testing for product validation and process validation on existing products
• Performed testing and prepared reports as required for investigations of non-conforming material, performance evaluations, QC Audits and special projects
• Responsible for analyzing data and tracking relevant trends, statistical analysis and trend analysis
• Documented and maintained all test and validation results and product release records (including electronic records)
• Completed Phlebotomy Training and Certifications towards In-Process Testing of Medical Device consumables
• Managed the Control (QC) laboratory and trained/ oversaw laboratory technicians
• Resolve product performance issues and maintenance of the documentation files of approved QC Standard Operating Procedures in compliance with FDA, GMP/ QSR, ISO-9001 and EN46001/ EN13485 Standards
• Tested biological raw materials and finished goods per relevant SOP
• Forecasted and maintained JIT Kan Ban inventory levels, laboratory supply levels, and optimal laboratory equipment operation in the QC laboratory

Confidential

Manufacturing Technician II

• Completed validation testing, in-process testing and functional testing of manufacturing processes
• Performed troubleshooting procedures, resolved semi-complex technical problems, and root cause analysis affecting daily operations to a development environment
• Exceptionally observant to note abnormalities in components, design, and inconsistencies with manufacturing schematics pertaining to medical device assembly
• Creative mindset to not only identify discrepancies, but also quick learner and help identify root causes for issues
• Helped develop production, quality, and product development forecasts arising from experiments and data analysis, maintaining JIT Kan Ban inventory levels
• Robotics & Manufacturing Automation process improvement, quality control, and quality assurance
• Worked with live and synthetic blood samples and reagent formulation for bio-hazardous applications
• Wrote, redlined, and evaluated seven SOPs.
• Collected data and reported findings in collaboration with SMEs in campaigns for process improvement and development of Automated Manufacturing
• Responsible for production support, development, and the quality of consumable components
• Experience with Plastic Production and Assembly including experience with Plastic Mixes and Reagents, Batch Record Review and general GMP
• Created fixtures Design and tools to enable completion of experiments and SMT development
• Executed semi-complex research and development and completed repairing and retesting of related processes
• Gathered and recorded semi-complex experimental information; entered data into internal computer systems

Confidential

Manufacturing Technician III

• Researched and developed product lines and completed functional, validation and in-process testing
• Led Reagent Instrument Manufacturing Team in production using GLP, GMP, IQ/OQ/PQ, FDA 21 CFR, and part 11 requirements
• Selected as one of seven employees to work as a liaison/trainer with outside vendors in overhauling, revamping, and validating processes toward ensuring vendor compliance with specific needs and requirements of the manufacturing process
• Wrote, designed, engineered, and implemented manufacturing techniques (SOPs), later training the entire Reagent Manufacturing Team on proper procedure including safety and state/local licensing regulations
• Collaborated with Environmental Health and Safety (EHS) Team in establishing safety specifications
• Assisted with the Packaging Team and finished goods inventory for Quality Control and Quality Assurance
• Wrote manufacturing production reports, analysis, production forecasts
• Assisted to troubleshoot reagent manufacturing which included the use of solid, liquid, and gas in processes
• Worked hands-on in research and development of DNA Contamination Instrument improvement via experimentation and performance trials
• Supervised product line inventory and purchasing of raw materials, supplies, and tool/instrument calibration
• Pioneered the design and implementation of data management for manufacturing, experiments and trials
• Promoted to Project Manager 2008 and increased production 120% from the previous year, increased production 50% in 2009, and eliminated waste by 30% in 2010