Experience

Noramco™

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Associate Manager, Quality Assurance

  • Jun 2022 - Present

  Wilmington, Delaware, United States

• Quality Assurance Specialist

  • Jan 2020 - Jun 2022

  Rhode Island, United States • Supporting the site in all areas of cGMP compliance, with emphasis on Quality compliance regarding Regulatory filings and coordination of activities formerly performed within Analytical R&D and transitioning to QC. • Provide Quality support for DMF and CEP filings and associated activities. • Responsible for Customer requests and creation of documentation as requested. • Oversight of QC systems include institution of best practices with regard to instrument qualifications… Show more • Supporting the site in all areas of cGMP compliance, with emphasis on Quality compliance regarding Regulatory filings and coordination of activities formerly performed within Analytical R&D and transitioning to QC. • Provide Quality support for DMF and CEP filings and associated activities. • Responsible for Customer requests and creation of documentation as requested. • Oversight of QC systems include institution of best practices with regard to instrument qualifications, training, reference standards, QC data and documentation, sampling, stability support, out-of-specification investigations, and data integrity. • Support of day-to-day manufacturing operations, including issuance of batch records, review executed batch records, issue certificates of analysis, perform inspection and release of class 04 materials. Also assist with document control including reviewing, filing, scanning and updating of site documentation. • Responsible for collection and verification of production data to support Annual Product Reviews. Coordinate collection and verification of data to support Annual Product Review (APR) reports. This would include data from batch records, investigations, change controls, OOS, suppliers and analytical testing. Additionally, Provide recurring detail-oriented QA oversight of the following key systems: USP Purified Water, Environmental (T&H) Monitoring, Pest Control and Instrument Calibrations. • Assist in internal and external auditing function to ensure compliance with CFR 21 regulations and ICH Q7 guidelines, EDQM, Health Canada and Part 11/Annex 11 compliance.


Usborne Books & More - Ocean State Books
• Team Leader

  • Apr 2016 - Present


Rhodes Technologies Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Research Scientist - Analytical Research and Development

  • May 2015 - Dec 2020

  Providence, Rhode Island Rhodes Technologies is your strategic partner in the United States, which is the world's largest pharmaceutical market. Our multi-purpose, FDA-registered and DEA certified plant has a complete range of active pharmaceutical ingredients (API) production capabilities, including process development, synthesis, drying, plus advanced micronization suites with state-of-the-art jet mills, as well as dosage form manufacturing suits. •Operation, calibration, and maintenance of HPLC, GC, FTIR, and… Show more Rhodes Technologies is your strategic partner in the United States, which is the world's largest pharmaceutical market. Our multi-purpose, FDA-registered and DEA certified plant has a complete range of active pharmaceutical ingredients (API) production capabilities, including process development, synthesis, drying, plus advanced micronization suites with state-of-the-art jet mills, as well as dosage form manufacturing suits. •Operation, calibration, and maintenance of HPLC, GC, FTIR, and other lab equipment. •Development and validation of analytical methods including transfers to Quality Unit. •Document author of Controlled Methods, SOPs, Internal Memos, and other laboratory documentation. •Analytical support of Product Research and Development, Quality Control, and Production departments. •Member of the Emergency Response Leadership Team responsible for overseeing training of ERT members as well as reviewing and improving on site wide responses. •Member of the Emergency Response Team - HAZWOPER Trained. •Member of the Laboratory Safety Team - Equipment Coordinator Show less



Rhodes Technologies

• Mauritius
• Computer and Network Security
• 1 - 100 Employee

• Associate Scientist - Analytical Research and Development

  • Aug 2012 - Apr 2015

  Providence, Rhode Island Area Rhodes Technologies is your strategic partner in the United States, which is the world's largest pharmaceutical market. Our multi-purpose, FDA-registered and DEA certified plant has a complete range of active pharmaceutical ingredients (API) production capabilities, including process development, synthesis, drying, plus advanced micronization suites with state-of-the-art jet mills, as well as dosage form manufacturing suits. •Operation, calibration, and maintenance of HPLC, GC, FTIR, and… Show more Rhodes Technologies is your strategic partner in the United States, which is the world's largest pharmaceutical market. Our multi-purpose, FDA-registered and DEA certified plant has a complete range of active pharmaceutical ingredients (API) production capabilities, including process development, synthesis, drying, plus advanced micronization suites with state-of-the-art jet mills, as well as dosage form manufacturing suits. •Operation, calibration, and maintenance of HPLC, GC, FTIR, and other lab equipment. •Development and validation of analytical methods including transfers to Quality Unit. •Document author of Controlled Methods, SOPs, Internal Memos, and other laboratory documentation. •Analytical support of Product Research and Development, Quality Control, and Production departments. •Member of the Emergency Response Leadership Team responsible for overseeing training of ERT members as well as reviewing and improving on site wide responses. •Member of the Emergency Response Team - HAZWOPER Trained. •Member of the Laboratory Safety Team - Equipment Coordinator

• Quality Specialist I - Quality Control

  • Jun 2010 - Aug 2012

  Providence, Rhode Island Area Rhodes Technologies is your strategic partner in the United States, which is the world's largest pharmaceutical market. Our multi-purpose, FDA-registered and DEA certified plant has a complete range of active pharmaceutical ingredients (API) production capabilities, including process development, synthesis, drying, plus advanced micronization suites with state-of-the-art jet mills, as well as dosage form manufacturing suits. • Performed critical testing on in process goods, finished… Show more Rhodes Technologies is your strategic partner in the United States, which is the world's largest pharmaceutical market. Our multi-purpose, FDA-registered and DEA certified plant has a complete range of active pharmaceutical ingredients (API) production capabilities, including process development, synthesis, drying, plus advanced micronization suites with state-of-the-art jet mills, as well as dosage form manufacturing suits. • Performed critical testing on in process goods, finished goods, and raw materials. • Assisted with inventory, transfer, and disposal of controlled substances. • Identify deviations, out of specification, and out of trend data. Assisted with review and testing of all deviations. • Reviewed control documents and procedures for accuracy. • Troubleshooting instrumentation problems. • Confirmation of data and laboratory Notebooks. • Created and maintained Column Inventory and use logs.



Cambrex

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Control Supervisor/ Stability Coordinator

  • Nov 2007 - Jun 2010

  Charles City, IA Quality Control Supervisor responsible for all operations of a cGMP compliant Quality Control laboratory testing a high volume of samples. Additionally responsible for entire Stability Program at Cambrex Charles City Inc. following ICH guideline (protocol writing, sets, pulls, reporting, statistical analysis, customer costings). • Training and assisting Chemists with all methods, instrumentation, and work priorities. • Allocation/scheduling of resources, including Chemists… Show more Quality Control Supervisor responsible for all operations of a cGMP compliant Quality Control laboratory testing a high volume of samples. Additionally responsible for entire Stability Program at Cambrex Charles City Inc. following ICH guideline (protocol writing, sets, pulls, reporting, statistical analysis, customer costings). • Training and assisting Chemists with all methods, instrumentation, and work priorities. • Allocation/scheduling of resources, including Chemists, instrumentation, and lab space. • Confirmation of data and releasing of raw materials and finished products. • Communication with Chemical Engineers, Production, Management, Quality Assurance, Analytical Development, Research and Development, and Materials Management on a daily basis to meet all company needs for both the QC department and Stability Program. • Troubleshooting instrumentation problems. • Responsible for answering all customer complaints directed to the QC department. • Member of Emergency Response Team, HAZWOPER technician level. • Participated in customer/FDA audits; taking auditors for tour through QC/Stability areas and answering all questions pertaining to the QC laboratory and Stability Program. • Performed Preventative Maintenance and Qualification on HPLC, GC, Headspace GC, UV-Vis, Karl Fischer, Auto-Titrators and other instrumentation. • Wrote, revised, and reviewed control documents and procedures for accuracy. • Maintained and re-qualified reference standards for the QC laboratory. • Transferred new methods from Analytical Development into the QC department. • Identify deviations, out of specification, and out of trend data. Assisted with review and testing of all deviations. • Stability Program contained over 50 ongoing compounds, upwards of 200 individual batches. • Maintaining inventory, temperature mapping, and maintenance of stability chambers. • Perform testing of stability samples as needed to ensure all stability is tested by due date. Show less



WIL Research Laboratories

• United States
• Veterinary Services

• Research Biologist General Toxicology

  • May 2007 - Nov 2007

  Ashland, Ohio •conducted detailed clinical observations •performed advanced dosing procedures •performed advanced behavioral observations