- Facilitated and supervised the transfer and/or development of methodology for the QC lab.- Performed QC testing for in-process samples and final product release.- Maintained lab instrumentation and coordinated preventative/scheduled maintenance with vendors. - Managed workflow of staff and production when group supervisor not on site.- Reviewed, maintained, and updated documentation related to the QC lab (SOPs, forms, reports, notebooks, etc.).- Assisted with the production process as needed.- Performed lab and production investigations.- Managed CAPA’s and change controls.- Analyzed and tracked historic data and product testing results trends.- Researched and managed the purchase of new analytical instrumentation.- Coordinated testing of raw materials and final products by outside labs as needed.

- Performed compendial method equivalencies with existing internal methods for drug products and API.- Performed method development, validation, verification, and troubleshooting for the analysis of drug products, excipients, and API in compliance with cGMP and regulatory requirements.- Performed gap analyses of current and prior validation reports and methods using ICH and internal guidelines.- Wrote protocols for method remediation, new technology validation, method validation, and method verification.- Authored technical reports, new methods, and initiated changes to existing methods and specifications.- Reviewed method validation and development data, technical reports, and protocols.

- USP method equivalency testing.- Method gap analysis.- Analytical method development, evaluation, trouble-shooting, validation, and verification.

- Analytical method development, evaluation, trouble-shooting, and validation.- USP method equivalency testing.- New technology evaluation and implementation.

- Performed multiple sample preparation techniques (digestion, extraction, removal of interfering metal species, etc.) on a variety of pigments (organic, inorganic, dispersions, pastes, etc).- Performed analyses of pigments for color content, chlorinated impurities, aromatic amines, and metals content using UV/VIS, GC/MS, LC, and ICP.

- Developed, wrote, and validated new analytical methodology (including training manual for Bruker 300 UltraShield NMR and Instrument Qualification) in support of polymer production and the Quality Control lab in accordance with ISO.- Assisted in method transfer and development for new product development and analysis (including wash out methods for monomers and initiators).- Assisted in investigations of material (raw material and final product) found to be out of specifications.- Developed and oversaw GR&R studies of existing analytical methods.

- Developed and wrote new analytical methods (wet chemistry and chromatographic) used in both QC and R&D environments for the analyses of water- and oil-soluble surfactants in accordance with ISO.- Evaluated, researched and trouble shot existing analytical methods used in QC and R&D labs.- Oversaw method validation, transfer and implementation.- Researched and managed the purchase of new analytical instrumentation.- Produced detailed lab reports and documentation.- Developed a detailed Round Robin method validation program.- Wrote and initiated an instrument preventative maintenance schedule for QC and R&D labs.

- Performed multiple sample preparation techniques (solvent extraction, de-fatting, simultaneous distillation/extraction (SDE), dilution, concentration, etc.) on a wide variety of materials (eatable tissue, cereals, milk products, alcoholic beverages, fats and oils).- Performed chromatographic (LC and GC) and mass spectrometric analysis of flavor mixtures and R&D reaction products.- Performed analyses of essential oils using GC/MS and GC/FID.- Wrote meaningful and helpful reports used by internal and external customers.- Performed general maintenance on GC and GC/MS instrumentation.

- Assisted in the design and construction of an aquatic toxicology dilution system for the mixing and delivery of environmental controls and test substances.- Assisted with the preparation of samples for chromatographic analysis, including dilution schemes and solid and liquid extraction under Good Laboratory Practices (GLP).- Assisted with basic routine maintenance of instrumentation, data collection and interpretation, and basic report writing under GLP.