Supervised laboratory activities in order to meet company production goals.Duties include: - scheduling and coordinating raw material and product testing to meet production schedules- ensuring lab result data integrity- training and mentoring analytical lab staff- writing laboratory deviations and investigations within a quality system- technical documentation creation, review, and revisement within a quality system- coordinating outside testing when required- interdepartmental collaboration to meet testing needs for product development/validation- internal and interdepartmental collaboration to meet quality guidelines and requirements- laboratory logistical problem solving to meet production schedules within a highly regulated quality environment- troubleshooting analytical data and connecting issues to laboratory conditions- reviewing and interviewing position applicants- ensuring and enforcing laboratory safety and etiquette- interaction with external vendors and service providers

- Performed quality control testing on raw materials, in-production, finished products, stability, and process validation samples in compliance with industry and client guidelines, regulations, and practices.- Testing performed on solid dosage (tablets, capsules), liquid products (including oral solutions, suspensions, and re-consituted samples), and raw materials. - Experience with UPLC (Acquity and Dionex/Thermo), HPLC (Waters - PDA/UV-Vis/RI), GC (6890,7890, direct inject/headspace/ autosamplers), integration with Empower version 2 and 3 software, Karl Fischer (volumetric), dissolution apparatus, UV/ Vis spectrophotometer, colorimeter, polarimeter, density apparatus (manual/auto), viscometers, FTIR, manual/automatic titration, manual particle size testing, and wet lab raw material testing. - Performed integration of data from samples run on UPLC, HPLC, and GC. - Experience with HPLC troubleshooting, integration troubleshooting, connecting HPLC/prep conditions to chromatogram issues, lab prep troubleshooting, and some GC troubleshooting.- Experience with method transfer and verification (testing and technical report drafting) from internal groups and outside client labs.- Processs validation testing on numerous new products- Cleaning validation by HPLC- Technical documentation drafting within a quality system- Interpreting USP, EP, various other pharmacopias, client methods, manufacturer methods, etc.

-Developed and validated 11 stability indicating HPLC analytical methods for new liquid and gel OTC products (Following ICH guidelines and USP monographs <1225>, <1226>, <621>).-Performed analytical method transfers to the QC department for all validated methods.-Performed analytical testing for 15 process validations of new products.-Provided support to the R&D Formulations group during development of new OTC drug products and dietary supplements using analytical techniques.-Assisted in training QC and R&D personnel for method validations and process validations.-Performed 14 secondary standard qualifications using USP and JP compendial methods.-Modified and verified compendial methods (USP/NF, JP) for API’s and excipient testing.-Developed 5 HPLC methods for dietary products.-Created, reviewed, and updated technical documentation such as test methods, SOP's, process/stability/validation protocols, and technical reports. -Systematically compiled and analyzed testing data to determine chemical/physical stability for raw materials, in-process materials, development products/processes, and finished products. -Aided in the initiation of a stability program for new OTC and dietary products.-Performed stability pulls, testing, data curation, and technical report updates.-Performed equipment maintenance, troubleshooting, and vendor interaction. -Collaborated with vendor technical analysts to choose cost efficient equipment and materials to perform analytical testing. -Analyzed raw materials, intermediates, and finished goods to determine quality, stability, compatibility, safety, efficacy, and nutritional value using analytical techniques.

Performed quality control testing on raw materials, in-production, finished products, and stability samples in compliance with FDA, DEA, and USP guidelines, regulations, and practices. Testing performed includes: dissolution, assay, disintegration, content uniformity, blend uniformity, alcohol content, water content, related compounds and impurities testing, color, pH, and product, packaging, sample assessment. Experience with HPLC (PDA/UV-Vis), GC (6890,7890), Karl Fischer, integration with Empower software, dissolution apparatus, UV/ Vis spectrophotometer, colorimeter, viscometer, FTIR, manual/automatic titration and wet lab raw material testing. Performed integration of data from samples run on HPLC and GC.

Spent a semesters rotation working on determination of the Vitis ripening mechanism. Focused mainly on mapping and coordinating data into Vitis cyc to show the biochemical pathway.

Testing technologist for a plasma processing center. Performed immunohematology screening assays in accordance with SOP procedures to ensure the safety and quality of the plasma or serum test results. Strictly followed GDP protocol and complied with cGMP standards to ensure integrity and quality of testing results. Experience with routine maintenance and maintaining maintenance logs, trouble-shooting instrumentation, calibration, and re-qualification of instrumentation. Proficient with test result interpretation and correlation of abnormalities in test results with instrumentation system conditions.

Supervised chemistry 1, 2, and quantitative analysis labs, provided background information on relevant techniques, general instruction and safety supervision, and tutored and graded student work.