Quality hot sauces with a variety of flavors and spice levels.

• Supports quality oversight for root-cause analysis and product impact assessment for investigations asa result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.• Supports change control assessments, implementation and closure• Identifies and facilitates continuous improvement efforts• Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed• Helps represents Vertex Quality on cross-functional working teams, applying strong communicationand collaboration skills.• Support continuous improvement projects

• Performs configuration management (CM) activities on various research and development programs with prominent customers such as the Navy, Air Force, NASA, and commercial bio-medical• Planning and executing EIA-649-style CM activities for new and existing programs with hardware and/or software deliverables using Draper’s web-based engineering data management system as well as a commercial product lifecycle management (PLM) system

• Assumed responsibility for control, filing, retrieval, and maintenance of master and reference documents. Responsible for electronic and hard-copy archival system for controlled documents.• Received and reviewed process controls. Tracked ECN, Product Release Approvals, and other documents per the relevant procedures. Managed document changes and approvals.

• Processed and maintain Quality System documentation for regulatory compliance of Rythmia Product in File with company in adherence to the BSC Quality Policy and maintain all quality records, policies and procedures.• Provided PDM, DMR support and solutions for Quality, Engineering and Project Management staff supporting Cambridge and Burlington sites

• Restriction of Hazardous Substances (RoHS) Declarations acquired for 2000 components, 100 vendors in less than one month, in order to maintain CE mark• Management of document control, including incorporating / processing changes, chairing the change review board. • Performs internal audits; issues audit reports and follows up to ensure timely closure of audit findings.• Serves as Quality System expert providing ongoing guidance and direction to Associates at all levels in the organization regarding Quality Documentation, Nonconformances, Deviations, Training• Advises cross-functional project teams on quality systems, product development/design control, supplier quality, and manufacturing quality.• Conducts/participates in supplier audits. Works with suppliers to ensure CAPA plans are developed and implemented for non-conformances identified.• Tracks and trends key quality indicators and issues monthly reports. Prepares presentations for Executive Management Review Meetings.• Assists the Management Representative during external (Notified Body, FDA, etc.) audits; ensures correction of identified nonconformities.

· QC data review and approval; Raw material QA support;· Stability and trending reports review and approval;· Laboratory Operations support;· QC Labs compliance assessments;· SOP review and approval;· Quality systems Deviations, OOS, CAPA, tracking and review.· Provide support for Development QC testing and Pharmaceutical Analytical Development

Quality Control Chemistry Analyst (Therapeutics)• Performed GC, SDS Page, HPLC, Atomic Absorption (AA), A280 protein assay, PNP activity assay, Bradford, TOC, UV/Vis Spectroscopy, Specific Gravity on Raw Materials, Intermediates and Finished Product Samples for Cerezyme• Performed assay validation, raw material and stability testing, qualification of new instrumentation• Authored Technical Report, Compendial Verification Protocols, Scheduled raw material testingQuality Control Analyst II (Diagnostics)• Performed Clinical Chemistry Assays (UV/Spec) on Amylase, Cholesterol, and Lipase, including finished goods/raw material release, stability, kit compatibility, value assignment, patient screening, data entry, and trending.• Maintained and troubleshot Chemistry Analyzers; collaborated with Field Service Engineers (c8000, Aeroset, Hitachi 911, Olympus, Cobas FARA, Dade).• Collaborated with Material Review Board in identifying root causes and implementing CAPAs.• Identified non-conformances in finished goods, inline production, raw materials, printed materials • Performed Bioburdens to ensure uncontaminated material, packed enzymes.

• Performed synthesis and purification of Phase I, II, & III Oligonucleotides (DNA/RNA) for clients under cGMP• Led Job Safety Analysis Team in proactively identifying hundreds of risk areas and to prevent hazards or injury.• Collaborated with Process Development in successful scale up of RNA synthesis process for outside customers.• Teamed with Engineering for successful implementation of larger scale process equipment and wrote detailed SOP for process use and identified key safety areas.• Presented with 2007 President’s Safety Award for reduced chemical exposure to chemists.• Organized lab and office areas as part of Lean Team responsibilities.• Created and transitioned SOPs using Formatting Solutions Pro to enhance readability and organization.• Demonstrated proficiency in Unicorn, Oracle, SmartSolve and Microsoft Office.

Cell Culture Associate, Production and ResearchEngineered 3-D tissue models of EpiDerm and EpiOcular kits for commercial sale as an alternative to animal testing.Collaborated with Research group by performing ELISAs, Histology, and Histotechnique.Successfully demonstrated Aseptic / Sterile Technique - no occurrences of contamination.