Help manage ARD's instruments fleet. To help organize protocols, projects, to qualify instruments for GMP use. Including protocols and projects to un-qualify instruments for GSP use, or for complete decommissioning.Also, write/review Result Summaries for completed qualification testing, to submit to QA for approval.OOT investigation and write up.Coordinate with different departments to help transfer equipment between sites/locations.

• Perform routine testing of Alternate API Raw Materials and Finished Product Exhibit Batches, including identification, assay, and impurity testing by LC, and any additional internal or compendium-specified tests• Write, review, and execute protocols for optimization, validation, and transfer of methods of analysis from internal sites, USP, European Pharmacopeia and external vendors• Write and technically review drafted methods, protocols, reports, and updates to controlled worksheets used by analysts, including submission and implementation through Documentum• Enter invalid run reports and conduct investigations in KabiTrack software for multiple analysts• Attend cross-functional 5S team meetings and implement laboratory organization and efficiency techniques• Support Technology Transfer, Raw Material QC, Finished Product QC, and Stability QC teams by performing routine testing as needed• Train new analysts from all quality control groups in basic techniques, instrumentation, and software as being a Qualified Trainer• Analytical Development and Study of HPLC & UPLC test methods of New Products• Validated and transferred analytical methods for drug substances, preservatives, and degradation/impurities in APIs and finished products in accordance to Fresenius Kabi LLC. Procedures, ICH guidelines, and FDA/International agencies regulations (HPLC/UHPLC/GC)• Investigated and addressed deficiencies from regulatory agencies; performs additional studies for regulatory submission (sANDA)• Authored and implemented change controls proactively for deficiencies in internal SOP’s and MOA’s

• Testing of Finished Product for release with 21 day deadlines• Performed routine testing for products including assay, impurities, identification, density, viscosity, pH, appearance, closure, dissolution testing, TLC, FTIR, AA, PM, Conductivity, and Titrations• Performed investigations on products with results out-of-specification (OOS) / out-of-target limits results (OOT) / out-of-expectations (OOE)• Maintained logbooks and laboratory notebooks in a cGMP environment over the course of employment• LIMS data entry and review• Trouble shooting instruments with training from Agilent, Waters, and LC Resources• On-call in-process testing• Work with Technical Transfer to test exhibit and protocol batches

Perform in accordance with USP, cGMP, and GLP for:-HPLC & UPLC for assay testing, pH, Visual examination, Uniformity of Dosage, Loss on Drying, FTIR, Particulate Matter,

- Formulating Batches per SOP’s, cGMP’s, GDP, and FDA Regulations- Using pH meter, UV/Vis Spectrometer, Oxygen Meter, Tachometer- Following product schedule and Fill Supervisor to assure products being on time- Weighing of Raw Materials- Sanitizing of Mixers, Tanks, filter assembly, parts, and post/pre filtration areas- Assembly of filters, Pre-filtration set up, and Post-filtration break down- Record and Write in Batch Records, Log Books, and Monitoring Log Sheets- Communicate with Supervisor any issues or concern in Compounding Department

Responsibilities included talking with consumers to sign up for a free inspection of their home for any weather damage. Driving other co-workers to their assigned locations, help evaluate storm impact on areas, and fill out paper work for insurances. Helped insert formulas on excel, setup projectors & computers, and organized paperwork.

Responsibilities consisted of overseeing new employees and projects, working in the office on excel spreadsheets, Microsoft publisher to create brochures, inventory check, talking to customers to set up appointments and customer service, ordering of products from our dealers, picking up products from our dealers, installation of low voltage equipment (such as mounting TV’s on the wall and over fireplaces, running speaker wires, security wires, coax wires, Cat5 & Cat6 wiring for telephones and networking, whole home automation, surround sound systems, security cameras, network cameras, CCTV’s, home alarm systems, speaker set up and mounting, volume controls and installation of PA systems), programming of Universal Remote Controls, programming of receivers, and structure wiring box.

Responsible for general cleaning such as: mopping, vacuuming, emptying trash containers, and cleaning office desktops