Quality Control Consultant (Quality Control Scientist)-Risk Assessments-Process Development-Use of 21 CFR Part 210 and 211-Understanding and Use of 503a and 503b applications in pharmaceuticals-Use of USP 795 and USP 797 -Prepare all Quality Control documentation for FDA NDA utilizing USP and ICH expertise-Conduct routine analysis of raw materials, intermediates, and final products independently-Assist in supporting day-to-day laboratory operations-Execute method development-Complete method transfer from Research and Development to QM/QC (quality measurements/quality control)-Perform and design stability studies-Independently generate sound analytical data and produce the associated technical reports-Conduct verification and/or validation of methods execution-Writing and/or approval of qualification, validation, and stability protocols and/or reports-Develop In-Process-Control test procedures-Perform QC testing and/or release of cGMP materials as needed-Review and approve analytical data and results-Write and approve QC and analytical documentation-Maintain Quality Control related documentation (QC SOPs and methods, test methods,analytical validation and/or qualification, reference standard qualification, and stability studies,specifications)-Maintain data within company data integrity standards-Assist with other analytical services as needed

•Gathering and analyzing and interpret gathered data, submit reports (LabVantage LIMS)•Finding patterns and trends in the analyzed data•Performs risk management, including identifying, prioritizing, and mitigating risks,and communicating and escalating risks and issues•Provide the ability to manage projects that may vary by project type (i.e., a newproject, an existing project, a project being transitioned from another deliveryprovider, etc.), size, complexity, project life cycle phases,•Support the development of briefings, agendas, and other general documentationsupport as directed, including training material and demonstration sessions fornew and existing technologies•Support a continuous improvement process by providing recommendations onimproving products, services, and processes•Prepare compounds, test solutions and reagents to conduct tests andexperiments, then advising and coordinating on test procedures•Determine the relationships of chemical and physical properties, composition,structures using chromatography techniques•Clean and maintain laboratory instruments and equipment, making sure that allthe technology is working correctly•Order laboratory supplies•Responsible to enter the test analysis results into the appropriate spreadsheet totrack and trend data for each study•Utilize KF, UPLC, GC and other chemical analysis equipment to assess productquality/small molecule.•Trained in GMP, GDP, SAFETY and other lab requirements•Analyze intermediate products using UPLC, GC, and others•Perform calibration and maintenance of UPLC, GC, and laboratory balances.•Perform work as a chemical analyst in a GMP production/FDA regulated facilitythat manufacture vaccines products•Experience in pharmaceutical or related industry in a laboratory setting, withknowledge of cGMP and related compliance regulations and guidance•Ability to interpret data, perform complicated analytical calculations/statistics

Responsibilities:- 4 years of Procurement using P2P, Coupa, Excel, Microsoft Teams for ordering, tracking, making adjustments, advancing requisitions, closing POs, and invoices- Microsoft Excel Descriptive Analytics- Microsoft Excel Statistical Analysis and Tracking Development - Ensure samples are analyzed according to scope of services offered while maintaining adherence to ISO 17025 and A2LA accreditation-Assisted in creation of Industry-Leading Cannabinoid Analysis service-Record, Track, Analyze, and Report sample/standard data to ensure process control-Utilize Excel, LIMS, Chemstation, and purchasing software to ensure lab's operational efficiency in regards to instruments, inventory, and data integrity.-Record meeting notes and track progress on actionable items. -Assist and track all laboratory research and development initiatives-Travel to sites within laboratory worldwide inter-company network to provide research and development and method development assistance-Attend workshops/webinars/conferences to remain abreast of current trends and innovative skills within industry which are then applied to create new services and improved methods-Calculate chemical application rates for sample entry-Complete solution calculations for internal standards, buffers, and mobile phases-Create Sequence for sample method run. -Follow standard operating procedures-Member and contributor to Lean/5S, Safety, and RCRA Hazardous Waste Committees-HAZMAT and RCRA Waste Disposal Certification-DATCP Certified Chemical Treatment Applicator

• Conducted chemical and physical analysis of raw materials, intermediates, final products, R&D samples, pilot plant samples, new product samples in the Development laboratory•Sample Preparation and Processing for HPLC, GPC, FT-IR analysis•Followed ASTM methods, after receiving work order/sample receiving, for analysis of all samples•Reported findings from all analyses, in periodic technical reports, to support customer-technical service relations•Communicated results to colleagues through presentations and via web conferences•Supported production facilities by conducting ongoing QC of products, logging all data, and traveling to the site to assess problems•Maintained detailed laboratory notebook to satisfy ISO 9001 certification•Disposed of waste per EHS guidelines•Utilized respirator with various cartridges, as needed, after EHS training and approval•Performed routine maintenance and calibration on instruments

• Calculate chemical application rates• Follow experimental procedure• Process samples via analytical balance, solution preparation, and vial preparation.

• Interfaced with customers, insurance, providers, and pharmacy staff• Manage inventory• Adhere to HIPAA regulations• Organize and dispense correct amount of medication per each prescription for pharmacist to review• Entered prescriptions in computer system as received and filed into record until filled.