Experience

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  IWM International LLC

  • Hanover, Pennsylvania, United States

  • Quality Assurance Manager

    • 2024 - Present
    • Hanover, Pennsylvania, United States

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  Next Breath

  • Moldova
  • Pharmaceutical Manufacturing
  • 1 - 100 Employee

  • QA/QC Manager

    • 2022 - 2023

    Led team of 6 (5 Quality Specialists and 1 Quality Assistant) and managed day-to-day quality assurance (QA) / quality control (QC) activities in a contract research organization (CRO) setting working on inhalation products. Oversaw quality management systems (QMS) and managed timely reviews / approvals of protocols, out of specification (OOS), out of trend (OOT), investigations, deviations, data binder release, certificates of analysis (COA), reports, test methods (TM), standard operating procedures (SOP), document change requests (DCR) / change control, corrective and preventive actions (CAPA), training (general, analyst qualification, good manufacturing practices (GMP), good documentation practices (GDP), etc.), equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and other lab documents within prescribed timelines and in compliance with applicable SOP, cGMP, cGLP, DEA, ICH, and FDA guidelines. Managed internal and external quality audit program. Site QA / QC representative. Worked cross functionally with all departments / areas of the site / company.

  • Quality Control Manager

    • 2021 - 2022

    Managed day-to-day quality related QC activities in a CRO setting working on inhalation products and led a team of 5 (4 Quality Auditors and 1 Quality Specialist), including overseeing quality issues related to laboratory analytical results and investigations as well as the performance of Quality Auditors and Quality Specialist. Managed review / approval of protocols, OOS, OOT, investigations, deviations, data binder release, COA, reports, test methods, SOP, DCR / change control, CAPA, equipment IQ/OQ/PQ, and other lab documents within prescribed timelines and in compliance with applicable SOP, cGMP, cGLP, DEA, ICH, and FDA guidelines.

  • Quality Specialist

    • 2017 - 2021

    Reviewed and approved all non-commercial release and non-IVBE (in-vitro bioequivalence) project documentation such as data binder release, protocols, OOS / OOT, investigations, deviations, COAs, reports, test methods, SOPs, and other lab documents per applicable SOP, cGMP, cGLP, DEA, ICH, and FDA guidelines in a CRO setting working on inhalation products. Oversaw equipment program.

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  Teva Pharmaceuticals (Formerly Allergan / Actavis / Watson / Alpharma)

  • Elizabeth, NJ (worked remotely from Maryland)

  • Audit Consultant (as a Consultant through Residuals and Elementals LLC)

    • 2015 - 2017
    • Elizabeth, NJ (worked remotely from Maryland)

    Audited/reviewed hundreds of Empower sample sets to assess chromatographic integration practices used during generation of data for results in a variety of solid oral dose (SOD) Abbreviated New Drug Applications (ANDA) filings with the FDA. These assessments were used as part of the Reviewer Qualification practices for the Analytical Research and Quality Control Departments.

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  Allergan (Formerly Actavis / Watson / Alpharma)

  • Ireland
  • Pharmaceutical Manufacturing
  • 700 & Above Employee

  • Metrologist

    • 2012 - 2015

    Developed a Metrology Department for our facility. Researched, procured, qualified, validated, calibrated, and maintained all lab instruments and equipment (either in-house or by 3rd party) according to SOP, cGMP, cGLP, DEA, ICH, and FDA guidelines.• Maintained an electronic database of all equipment in Calibration Manager software in order to efficiently track all equipment locations, calibrations, and maintenance.• Drafted, reviewed, and revised SOPs for lab equipment and Metrology programs to ensure all current practices were documented and all regulations met.• Indirectly managed dozens of Field Service Engineers (FSE)/contractors from various equipment manufacturers to oversee the scheduling of their work to install, qualify, conduct preventative maintenance (PM) and/or repair equipment.• Managed for all service agreements/contracts in place with our vendors in order to achieve cost savings where applicable and maintain continuous service coverage.• Drafted, reviewed, and/or approved qualification protocols and reports to ensure all equipment met company and regulatory requirements.• Drafted, reviewed, and/or approved deviations and investigations as needed to track for Quality Assurance purposes.• Managed the decommissioning of all site equipment as part of site closure. Including “end of use” calibrations, close-out paperwork, de-installing equipment, packaging equipment, shipping equipment, and completing DRT forms for all assets transferred to other sites, sold to other companies, or donated to schools.• Handled all facilities issues/concerns during the site closure.• Liaison to all vendors, contractors, property manager as well as our corporate Environmental Health & Safety (EHS), Real Estate, Global Procurement, Legal, and Senior Level Management to coordinate site closure and provided updates throughout the shutdown.

  • Research Scientist

    • 2002 - 2012

    Worked as part of semi-solid and liquid (SSL) method development & validation team by performing accurate and efficient physical, raw material, GC, and HPLC testing according to SOP, cGMP, cGLP, DEA, ICH, and FDA guidelines.• Developed and validated new analytical methods for finished drug product, drug substance / active pharmaceutical ingredient (API), and related substances in support of ANDA filings. Peer reviewed / audited lab notebooks and other cGMP documents.• Performed physical, gas chromatography (GC), and high-performance liquid chromatography (HPLC) stability testing as needed in support of ANDA filings. Data is acquired using Waters Empower and stored in Sample Manager / LIMS (Laboratory Information Management System) database.• Performed IQ/OQ/PQ on instrumentation throughout the R&D lab.• Qualified Total Organic Carbon (TOC) analyzer for purified water system validation.• Generated, implemented, and updated new SOPs for various functions in R&D lab.• Completed problem solving and troubleshooting regarding analytical instrumentation and methodology.• Generated clearly understood methods, protocols, reports, specifications, certificate of analyses, SOPs, and other documentation in support of ANDA filings as well as completed data review.• Provided support for FDA Remediation efforts of Windsor Production Facility and quality control lab.• Peer audited laboratory notebooks, methods, protocols, reports, specifications, certificate of analyses, SOPs, and other documentation in support of ANDA filings as well as completed data review

  • QC Chemist

    • 1999 - 2002

    Worked as part of a manufacturing site QC Lab production support team by performing accurate and efficient In-Process, Wet Chemistry, Raw Material, and HPLC testing on In-Process, Finished Product, Stability, Validation, and Customer Complaint samples according to SOP, cGMP, cGLP, DEA, ICH, and FDA guidelines.• All HPLC data acquired using Waters Millennium32 and all data entered and stored in LIMS database.• Performed tests and assays such as pH checks and adjustments, conductivity, viscosity, particle size, density, volume checks, specific gravity, IR, TLC, auto-titration, melting range, water verification, and centrifuge tests for air content, sediment, and true density. TOC testing to verify quality of water for compounding. Performed Quality Control checks of compounded materials and disposed of hazardous waste materials and CDS samples.• Trained new employees on proper methods/techniques.• Created, updated and implemented various SOPs throughout the QC lab.• Helped other Chemists troubleshoot problems that occur during testing.

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  Washington Quality Foods

  • Ellicott City, MD

  • Lab Technician

    • 1999 - 1999
    • Ellicott City, MD

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  EA Labs

  • Sparks, MD

  • Extraction Chemist

    • 1998 - 1998
    • Sparks, MD