1. STAEL DUMESLE
868 S. 20th
St. Newark, NJ 07108 973.704.0039 stael77@gmail.com
SUMMARY
Analytical, quality-focused engineer with extensive experience directing and enhancing complex scientific projects
against aggressive metrics. Diverse research experience includes cell culture, SDS-PAGE gel electrophoresis, gas
chromatography, aseptic technique, and high-pressure liquid chromatography. Articulate communicator skilled in
resolving customer complaints and working across teams to drive full cross-functional collaboration. Academic
background in drug and product development, Total Quality Management.
Areas of Expertise:
Scientific Research • Project Management • Quality Assurance • Strategic Planning • Laboratory Processes
Product & Process Validation • Raw Materials Management • Performance Specification Modeling
CGMP/ISO/CFR/FDA Regulations • Compliance • Root-Cause Analysis • Inventory Control • Reporting • JD Edwards
•Statistical of variance (ANOVA) • Design of Experiment (DOE) •Microbiology: Aseptic Techniques, Gram Staining •
Biochemistry: HPLC, GC, SDS-PAGE
EDUCATION
MS, Pharmaceutical Systems Management (Anticipated 2015), New Jersey Institute of Technology
BS, Biology, 2007, Montclair State University
AS, Biology, 2004, Essex County College, Newark, NJ
• Served as lab assistant at the Biochemistry lab, providing quality support, lab preparation and equipment
sterilization
PROFESSIONAL EXPERIENCE
INTERNATIONAL TECHNIDYNE CORP. Edison, NJ
QC Analyst II September 2011 – Dec 2014
• Plan and direct high-priority projects in line with all requirements and technical review team
requirements
• Collaborate heavily with R&D, Clinical Affairs, and Quality Engineering to define and assess project scopes
• Guide and mentor quality control personnel on lab processes, equipment maintenance, and systematic
errors
• Perform QC inspection on medical devices as per the Standard operating Procedures (SOP’s)
• Conduct pre-inspection internal audits to assess areas of regulatory risk in preparation for
inspections/audits by FDA or ISO
• Provide thorough, timely and accurate responses to customer complaints
• Work with various functional groups to investigate, resolve, and relocate non-conforming material with
known performance issues,Knowledge and application of Six Sigma ,ANSI/ASQ Z1.4 Sampling Plan and
Statistical Analysis
• Performing investigations related to product complaints and non conforming events to ensure compliance
to FDA and other worldwide health authority cGMP regulations and guideline, site SOP’s and industry
standards
• Presents product complaint information or non- conforming events,independently, to in house client staff
and if appropriate, to to the responsible individuals at service providers
• Assists with the review of internal and external SOP’s as related to investigations
• Maintains quality documentation files, databases and logs
• Tracks metrics and trends as well as compliance issues and their resolution on a periodic basis
• Participates in determination of and recommends Corrective And Preventive Action of investigations and
reviews implementation of corrective and preventive actions
Key Contributions
• Improved assay development methodology through initiation and development of test validation ( IQ,OQ,PQ)
• Assessed and mitigated project risk via utilization of Engineering Change Order (ECO) and CAPA from initiation
to certified review Board (CRB) approval

2. • Initiated corrective actions to address deviations in standard operating procedures
• Trained current and new employees in Compliance to 21 CFR part 820 , 21 CFR 210,21 CFR 211,21 CFR 11, 21
CFR 58, ISO 13486 and FDA regulation
QC Technologist I Nov. 2007 – Sep. 2011
• Tested biological raw materials and finished goods in preparation for product release
• Tested currently available products for process validation to support established quality objectives
• Conducted extensive investigative testing of non-conforming materials and designated appropriate relocation
• Delivered extensive training for new hires related to finished product processes for SOP compliance
• Prepared detailed test result documentation/reports and maintained complex product release records
Key Contributions
• Implemented lean inventory supply management system with safety stock in order to ensure optimal levels of
material availability
• Achieved biomedical device standardization through utilization of cGMP and FDA expertise
AFFILIATIONS & COMMUNITY
Volunteer, Essex County College Student Center and University of Medicine and Dentistry-New Jersey Recovery Room