Kristen Meline

Responsible for evaluating PM systems for efficiencies and improvement. Will maintain complex files and document management systems and work with project teams to release company products; drug, substance and drug product. in charge of maintaining, organized and accurate record of all product specification, documents and correspondence with partners, vendors, customers, contract Labs, etc. continuously monitor the progress of assigned projects and communicate timelines to senior leadership and executive staff. Will create and use Gantt charts, spreadsheets and other appropriate tools to manage project. Focuses on proactive. planning to manage risk, remove barriers, and meet goals. Facilitates meetings and keep them effective by defining concise agenda acting as a timekeeper summarizing actions and maintaining records. Support quality and regulatory affairs when needed to include assistant preparation of the site for customer and agencies inspections. Facilitate resolution of issues, concerns, problems with internal and external parties. Serve as a customer lease on between internal departments and customers.

Responsible for coordinating a variety of projects related to regulatory affairs and compliance, business administration, as well as research and reporting. Provide direct administrative support to the Compliance and Regulatory Director as well as other internal leaders as needed. Regulatory Affairs Conduct data research and analysis to support product development from inception to final filing to ensure regulatory compliance and alignment with industry best practices. Apply ISO standards to company product development and procedures. Maintain knowledge of emerging standards, regulations, and compliance guidance documents. Business Administration Provide administrative support to internal projects to drive efficient business operations across the company. Offer administrative support and document control to ensure projects are managed according to company SOP’s and ISO standards. Research and Reporting Mine for information and compile data used for technical documentation. Conduct technical review of data and reporting to ensure accuracy and compliance. Track and document sample information, product formulas, and other scientific results to support technical and product development teams.

Responsible for researching and analyzing parenteral drug formulations leading to the creation of analytical methods and standard operating procedures. Perform method validations and transfers as well as create reports for submission to the FDA. Quickly advanced to positions of greater scope and responsibility; earned two employee awards based on excellent performance. Key Value and Achievements: • Developed and validated test methods for the analysis of raw materials; API’s, and finished products in compliance with ICH guidelines and USP/EP criteria. • Determined potency, purity, and product stability as well as other crucial quality attributes of submitted samples using developed test methods. • Completed sample analysis and generated data results per FDA data integrity requirements. Interpreted, reviewed and reported results according to strict SOP’s and industry guidelines. • Led an initiative to update and overhaul company SOP’s to improve quality and compliance. • Identified critical quality attributes of project formulations to determine necessary testing; researched new instrumentation options and became team’s instrumentation subject matter expert. • Collaborated effectively with multi-disciplinary teams to streamline and improve processes. • Assisted with investigation of OOS results and completed risk assessments, DCA’s and CAPA’s. • Acted as the Lead for the Safety Committee team; scheduled monthly meetings, created and facilitated safety training presentations and workshops. • Enforced proper use of PPE and performed regular safety audits to ensure compliance related to waste management per RCRA and employee safety per OSHA regulations. • Conducted cross-training of new hires to safeguard quality and enhance team performance.

Coordinated receiving samples, entering samples into LIMS, sample preparation and analyzation of samples per LC-MS. Reviewed and reported results via LIMS to clients within 48-hours. Maintained lab inventory and supplies per allotted budget. Key Value and Achievements: • Received and entered samples into the LIMS in an accurate and timely manner. • Inspected all incoming samples, maintained proper chain of custody, prepared instrumentation and samples for analytical testing per SOP guidelines and industry best practices. • Built and assembled sample waves; answered phones, consulted with physician offices, coordinated with insurance companies and sales representatives to ensure excellent customer service. • Completed drug test screening via ELISA followed by drug confirmation via UPLC-MS. • Performed sample, solution, and instrumentation preparation for analytical testing of samples. • Documented, reviewed, and reported drug analysis to clients within mandated 48-hour time period. • Monitored, stocked, and maintained lab supplies in Quartzy, a lab management software system. • Successfully lowered costs of testing by controlling purchasing and inventory management.

Western EcoSystems provides environmental and statistical consulting services and research nationally and internationally for industry, government, and private organizations to solve natural resource problems. Key Value and Achievements: • Conducted standardized fatality searches beneath wind turbines to locate bird and bat fatalities. • Performed Golden Eagles, Ferruginous Hawks, Sage Grouse studies at 2 to 4 a.m. • Carefully followed all field and data entry protocols to ensure accuracy and consistency of data. • Worked independently and utilized compass, GPS, range finders, and binoculars to locate test sites. • Worked in extreme weather conditions and rugged settings while maintaining quality.