SUMMARY:

• Providing both Consulting and Full - time professional services with Specialties ranging from “Regulatory Affairs/Quality Assurance and Safety” to “Laboratory QA/QC” in the Pharmaceutical, Chemical, Public Safety, Food Science, and Cosmetic/Perfumery fields.

TECHNICAL SKILLS:

• Documentation Management Specialist. Technical Writer. Pharmaceutical Standard Operating Procedures (SOP) Editor, Author and hands-on Trainer. International Chemical Testing Monograph Editor. (USP, JP, BP, Compendial Resources, etc.)
• Quality and Regulatory Management in both Laboratory and Manufacturing environments. cGMP and cGLP Expert. (i.e. current Good Manufacturing Procedures and current Good Laboratory Procedures Expert in the Pharmaceutical field)
• Quality Control Chemistry, Microbial Testing, Physical Quality Testing. Invesigator of OOS (Out of Specification) Results. Manufacturing Cleaning Validations and Investigations.
• Manufacturing Batch Record Review and Reconciliation.
• FTIR, HPLC, ICP, IR, Optical Rotation, UV-VIS, pH, Conductivity, Viscosity, LOD, BOD, Extractions, Heavy Metals, Nitrogen Digestions, Titrations, Hazardous Materials, Radioactive Materials, Use of PPE (Personal Protective Equipment), Specific Gravity, Color Matching, etc.
• DNA Sequencing, Microbiology, Aseptic Techniques, and Quality Control / Quality Assurance
• Food Science and Fragrance/Cosmetic laboratory experience. Chemical (including soaps and Cosmetic) and Perfume Compounding.
• Phlebotomy, Clinical Sample preparation.
• Water and Soil testing techniques.
• MSDS (Materials Safety Data Sheets) Coordinator and Editor for both the Manufacturing World and the lay person.
• Trainer / Tester / Teacher in Laboratory, Manufacturing and Classroom environments.
• Computer skills: Outlook, PowerPoint, Word, Excel, Visio, SAP, LIMS, Documentum (Document Database), TrackWise (Document Change Control System), etc.

PROFESSIONAL EXPERIENCE:

Confidential, Valhalla, NY

Formulation Documentation Management Administrator

Responsibilities:

• Participated in the administration of Formulation Documentation Management for FSS and FSS-DM Documentation Management Systems.
• Assisted in resolving issues with Formula Approval and management.
• Special projects for cleanup of migrated Formulations.

Confidential, White Plains, New York

Regulatory Labeling Manager

Responsibilities:

• Performed approvals and revisions on packaging and Labeling. This included Proofreading of Nutritional Fact Panels, Ingredient List and all Claims in a FTC and FDA regulated environment.
• Used the Artemis data management system, as well as Lotus Notes, Outlook, etc.
• Composed Ingredient lists from Master Formulation data provided by Research and Development.
• Managed, and successfully completed, the Nevada State Dairy Commission Re-licensing Project for all Confidential ’s dairy products sold in that state.

Confidential, Mahwah New Jersey

Regulatory Documentation Administrator

Responsibilities:

• Performed revisions, edits and proofreading of Standard Operating Procedures and forms in a GMP and FDA regulated environment.
• Used the Windchill documentation management system.

Confidential, Tarrytown, NY

Regulatory Affairs Specialist III

Responsibilities:

• Prepared regulatory submissions for in vitro diagnostic products for international registrations.
• Assisted in preparing reports for product registration and re-registration.
• Reports focused on substantiating product stability and performance claims.
• Performance claims included Precision, Linearity, and Calibration Intervals.
• Stability claims included Shelf-Life and On-System Stability of Reagents, Controls and Calibrators. Performed detailed research to compile the necessary study data for each of the reports and submissions.
• Siemens uses electronic document archives, databases and product lifecycle management (PLM) software including eBrite, Teamcenter, and Documentum.

Confidential, Parsippany, NJ

Regulatory Affairs Specialist

Responsibilities:

• Maintained, updated, and managed Safety Data Sheets (SDS) for all products, including household, personal care, and healthcare.
• Interfaced with Product Safety, Regulatory, R&D, and Supply Transportation personnel to discuss/clarify projects and informational needs for SDS generation.
• Maintained, updated, and managed internet website for ingredient disclosure and SDS of all products for North America (US and Canada).
• Generated Ingredient listings from the specific formulation in production.
• Interfaced with Regulatory and R&D on a routine basis to discuss formulations, raw materials, and informational needs including nomenclature harmonization.
• Authored Standard Operating Procedures for use of the Confidential North American Product Information Administrative Website and the Citrix/TDS - Lotus Notes database.
• Performed individualized training for new hires on the Standard Operating Procedures.

Confidential, Woodcliff Lake, NJ

Pharmaceutical Labeling & Proofreading Technician

Responsibilities:

• Performed proofreading of inserts, container labels, etc. in various stages of production.
• Generated new and revised package inserts, medication guides and container labeling.
• Prepared side-by-side comparisons of labeling for FDA submissions.
• Highlighted and mounted labeling for FDA submissions (ANDA/amendments/supplements).
• Maintained accurate count of monthly proofread items utilizing a database.
• Researched current referenced product text using the FDA’s and other official websites.
• Signed and approved new reprinted inserts, labels, etc., for Labeling Coordination dept.
• Created detailed indexes for both archived and active ANDA Submissions, their Amendments, Supplements and Annual Reports.
• Performed other duties, as assigned, or as business needs required.

Confidential, Rockaway, NJ

Customs Specialist

Responsibilities:

• Performed research to define the necessary factors involved in assigning the Tariff Classification for each material.
• This information included the chemical structure, chemical classifications, common uses and more.
• Corresponded with sources both foreign and domestic to facilitate the flow of necessary information in the Tariff Classification process.
• Performed operations using the SAP database system.

Confidential, East Rutherford, NJ

QA/Regulatory Manager

Responsibilities:

• Edited and created Standard Operating Procedures (SOP) and Forms.
• Created MSDS (Material Safety Data Sheets) for new products and updated the MSDS for existing products. Compiled complete MSDS file for finished products.
• Reviewed, performed proofreading, and approved Official CCA Product Ingredient Lists, and Weights and Measures Statements for Packaging and Labeling.
• Performed and documented laboratory weights and measures confirmation tests for finished products.
• Confirmed packaging components and compiled their technical drawings for each product.
• Performed and documented finished product freeze-thaw studies.
• Maintained all Regulatory files including Vitamin Supplements, Sun block and Cosmetic products.

Confidential, Mahwah, New Jersey

Document Control Administrator

Responsibilities:

• Processed change controls for editing, proofreading and creating Standard Operating Procedures (SOP) and Product Specification Data Sheets (PSDS).
• Distributed revised SOP’s and PSDS for training and use in production.
• Maintained files of official PSDS and SOP’s as well as Process Validations and Cleaning & Sanitization Validations.

Confidential, Union, New Jersey

Documentation Management Specialist II

Responsibilities:

• Revised compliance documents (SOP’s) assuring that draft documents accurately reflect requested changes using MS Word, Excel, Visio, Documentum, and TrackWise.
• Processed revisions in conformance with Level II standards and policies for good documentation practices and change management.
• Ensured draft document quality and performed proofreading. Submitted supporting documentation for filing when a document is approved.
• Performed Management of draft documents through review, approval and distribution process.
• Provided status updates to customers and Documentation management on work assignments.
• Participated in ongoing training programs related to current cGMP’s, job function, and safety.
• Compiled and presented performance Metrics for the entire NJ Change Administration Department using graphs and charts using Excel and TrackWise.
• Partnered with functional areas (Microbiology Labs, Analytical Labs, Packaging, Manufacturing, Validation, etc.) to facilitate the change control process.
• Assessed all Confidential USP Raw Material Monographs against compendial resources.
• Wrote "International Change Authorizations" and "International Work Requests" to affect change controls.
• Updated Raw Material Monographs with approved changes.
• Performed troubleshooting for international partners related to securing necessary data and background information as required updating monographs used internationally.

Confidential, Mount Vernon, NY

Quality Control Manager

Responsibilities:

• Managed Quality Control Laboratory. Evaluated quality of creams, liquids and ointments, etc.
• Performed root cause investigations and resolutions on out of specification and micro contamination issues.
• Performed daily Quality Control Inspections of all Production Lines and Warehouse Facilities.
• Reviewed and authorized Work Orders for Batches and Finished Products.
• Updated Packaging, Raw Material and Finished Product Specifications.
• Performed Research and Development projects in formulation and stability for new OTC pharmaceutical products.
• Wrote change controls for SOP's as needed.
• Performed proofreading for packaging and labeling as required.

Confidential, West Caldwell, NJ

Quality Control Chemist

Responsibilities:

• Performed analytical testing on pharmaceutical raw materials and finished products.
• Trained employees on new SOP’s.
• Wrote multiple Change Controls/Corrections for SOP’s and Monographs.
• Maintained and crosschecked lab report and instrumentation notebooks.
• Executed hazardous materials testing and sampling in appropriate PPE (Personal Protective Equipment).

Confidential, Elmsford, NY

Assistant Director of Quality Assurance

Responsibilities:

• Investigated finished product production yield discrepancies. Compiled complete MSDS and COA files for SAN MAR products.
• Assisted in overseeing the quality of batch production and packaging of finished product in a manufacturing setting. Evaluated quality of creams, liquids and ointments, etc. Facilitated the customer approval of product and components.
• Created protocols for Cleaning and Process Validation for over the counter Pharmaceutical products produced by SAN

Confidential, Pearl River, NY

Pharmaceutical Quality Control Chemist

Responsibilities:

• Tested pharmaceutical raw materials for Percent of Active Ingredients and Chromatographic Purity using HPLC. Tested raw materials for vitamin supplements.
• Performed a wide variety of USP Pharmaceutical Raw Material Analytical Testing Protocols including Heavy Metals, Lead, Mercury, Arsenic, Foreign Matter tests, etc.
• Conducted Official Investigation Reports on production lots of Raw Materials with Out of Specification test results.
• While working as a QC Chemist, I discovered errors in Laboratory Monographs and performed multiple Change Controls correcting those errors and others.
• Authored original Standard Operating Procedures (SOP’s) for the use of new laboratory equipment. Revised existing SOP’s for a higher degree of clarity, accuracy, conciseness, consistency and practicality.
• Served as part of an Official SOP Review Team set up to ensure adherence to strict FDA Compliance Guidelines.
• As part of this team, I networked with chemists in other laboratories within the Quality Control Department of Wyeth-Ayerst to effectively review, and re-write if necessary, our entire laboratory Standard Operating Procedures.

Confidential, Stamford, CT

Quality Assurance Lab Technician

Responsibilities:

• Performed dye tests on multiple types of hair dyes. These entailed color matching on wool gabardine, multi-fiber cloth, and human hair of various types.
• Completed safety training, including special hazardous materials training seminars.
• Executed viscosity tests with RVT, LVT, and Cannon-Fenske viscometers.
• Performed quality testing on all finished products including liquids, ointments, and creams.