Hermine Voltaire

About Hermine Voltaire

8 years of experience in a chemical environment with experience in creating documentation for operation, maintenance, calibration, troubleshooting and with a strong understanding for EPA/FDA regulations. • Proficient with instruments such as water spectrophotometer, TOC analyzer, endosafe MCS, pH conductivity meter, biosafety cabinet, caliper and micrometer as a product release analyst. • Experienced with medical device / pharmaceutical industry and able to critically evaluate and troubleshoot equipment and test procedures. • Familiar with cGMP and cGLP lab notebook documentations. • Responsible for CAPA investigations and deviations, Non-Conformant Products, Out Of Specification results, Track Wise database maintenances JDE and SAP. • Trained for product release activities including control, maintenance, review and reconciliation of Device History Records (DHR). • Performed diverse safety and environmental deliverables in multiple business and manufacturing environments including laboratory-based settings, clean rooms, Research and Development groups and pilot batches. • Experienced complying with quality regulations in QA role (including FDA QSRs, ISO13485), EPA regulations (including 72 FR 17068) and OSHA / PPE regulations. • Experienced with hazardous materials and questions related to health and safety industry. • Knowledge of measurement systems analysis, Minitab and proficient with computer tools such as Word and Excel. • Able to evaluate current equipment, products, facilities and processes; as well as those planned for future use. • Able to function well in a team environment. • Proactive in developing strong professional relationships with peers, product scientists, engineers, suppliers, contractors and manufacturers.

Experience

1. Scientist 2, Qc Microbiology Microbial Manufacturing Services (Mms)

   Thermo Fisher Scientific

   May 2022 — Present · CA, US

   Perform SAP Data Entry and transactions. • Perform environmental monitoring of a biological production facility according to written procedures, while fully gowned, including operational monitoring and personnel monitoring during aseptic processing and filling. • Oversee aliquoting/sterile filling operations and ensure acceptable aseptic techniques are employed on the floor. • Qualify and perform microbiological testing such as bioburden, bacterial endotoxin, microbial growth promotion and biological indicator testing. • Draft SOPs, Test Records, Qualification Protocols, Finished Product Validations, Out Of Specification Environmental Investigations, Deviations, Summary Reports and any supporting documents (Reagent Preparations, Equipment SOPs etc.). • Review EM data, analyze and summarize data with guidance. • Order laboratory supplies on specific platforms such as ARIBA and maintain required laboratory inventory according to SOPs. • Perform laboratory and equipment cleaning and preventive maintenance and calibration. • Read and report microbiological test results. • Perform Gram stains, titrations and arrange shipments of samples to contract labs for identification. • Maintain and ensure safe laboratory practices. Also draft and review Job Hazard Analysis for assays. • Perform sample logging on LIMS and assist with shipment preparations. • Provide support for GMP manufacturing activities and release testing.

Education

• State University of New York at Plattsburgh

  Master of Art in Liberal Studies, Concentration in Organic Chemistry

  2004

• State University of New York at Plattsburgh

  Bachelor of Sciences (B.S.), Cellular Biochemistry

  2000 — 2004

• State University of New York at Plattsburgh

  Bachelor of Arts (B.A.), French

  2000 — 2004

Skills

• Technology Transfer
• Change Control
• Raw Materials
• Talent Acquisition
• Regulatory Affairs
• Purification
• Chemistry
• Lims
• Internet Recruiting
• Research and Development (R&D)
• Resume Writing
• Validation
• Mass Spectrometry
• Sourcing
• Biochemistry
• Hplc
• Quality System
• Employee Relations
• Technical Recruiting
• Microbiology
• Gas Chromatography
• Interviews
• Standard Operating Procedure (Sop)
• Pharmaceutical Industry
• Sop
• Fda
• Applicant Tracking Systems
• Staffing Services
• Analytical Chemistry
• Personal Care
• Quality Assurance
• Glp
• Laboratory
• Formulation
• Organic Chemistry
• College Recruiting
• Recruiting
• R&D
• Contract Recruitment
• Talent Management