Brooke Chatelain Email & Phone Number

Salt Lake City, Utah, United States

Test new and repaired instruments that our customers use for patient testing to ensure they are performing to our standards before shipping them out. Maintain the Reagent QC’s fleet of instruments they use in product testing.-Perform quality control testing on newly built and repaired BioFire FilmArray and SpotFire instruments to ensure they are functioning properly to perform PCR.-Responsible for environmental swab collection, testing, monitoring, and reporting.-Troubleshoot any problems with PSL and UV hoods, instruments, pipettes, or other pieces of equipment or software utilized in pouch or instrument testing.-Perform calibration and preventative maintenance on pipettes, UV hoods, and FilmArray and SpotFire instruments.-Coordinate any repeat testing as needed.-Data entry and record maintenance for QC testing.-Generate Non Conformance Reports.-Report daily metrics to management.-Perform quality control testing on new pouch lots.-Validate new equipment and instruments that are brought into the Reagent QC lab.-Update SOPs as needed for the integration of new software and processes.-Work closely with QC managers, Instrument Production/Service Center leads, and Reagent QC to ensure consistent and timely turnaround for QC results.-Train new Instruments QC technologists.

Salt Lake City, Utah

Coordinated the movement of products for a leading syndromic infections disease diagnostics company.-Oversaw the flow of FilmArray products from manufacturing to sale through targeted software, detailed spreadsheets, and relevant email communication.-Identified issues in the product tracking system, partnering with appropriate groups to reduce product non-conformance and improve turnaround times.-Obtained and displayed advanced knowledge of BioFire Diagnostics’ Quality Systems.-Collaborated on the streamlining of component qualification process delivering better traceability.-Partnered with the quality department in testing product, requesting lots and components as needed.-Assembled and established the needed equipment for the quality technicians while following SOPs to ensure sterility and integrity of the product.-Discovered quality problems early on in testing and provided appropriate resolution.

Salt Lake City, Utah

Provided support for clinical studies, maintaining point of contact with subjects, and assisting with the execution of ongoing projects for a clinical research organization.-Protected patient privacy by conforming to HIPPA regulations.-Ensured all procedures were completed on schedule in accordance with the protocol, FDA, and IRB requirements.-Educated patients on the history, risks, and procedures during the informed consent and adequately answered questions prior to document signing. -Performed basic medical procedures including obtaining medical history, vital signs, ECG, urine collection, phlebotomy, and assessing of adverse events.-Maintained the medical equipment utilized in screenings.-Communicated cross functionally with principal investigators, medical providers, research teams, quality associates, and subjects to ensure data integrity.-Developed rapport with subjects creating a comfortable environment for disclosing important medical histories and any adverse reactions that were experienced.-Monitored subject safety and assisted with any reactions that occurred.-Coached, developed, and trained new associates, resulting in proficiency in performing studies.

Performed testing and extensive documentation on all testing procedures for a global contract research organization.-Partnered with cross functional groups to perform testing in compliance with protocols written for each client.-Maintained bacteria culture lines for use in testing.-Built specialized testing apparatuses for the type of testing being conducted resulting in data that clients could use to help their products get FDA approved.-Conducted testing on client samples with numerous strains of bacteria and mold using a variety of laboratory assays, documenting timely, comprehensive results.-Provided problem resolution for testing complications and ensured timeliness and compliance with the protocol, SOPs and WIDs.-Analyzed testing results to determine sufficiency and product success, and informed study directors of potential problems and results.-Prepared reagents and testing media.-Tracked inventory and condition of clients’ samples.-Maintained a well sanitized and organized BLS2 lab, including the daily cleaning and calibration of laboratory equipment.-Performed testing in a BSL3 lab as needed.

Sandy, Utah

Maintained machinery, collected and tested plasma, and provided accurate documentation for a multinational pharmaceutical manufacturer.As a phlebotomist:-Performed venipuncture for regular plasma donations as well as to obtain blood samples for additional testing.-Maintained proper documentation though good documentation practices, ensuring traceability.-Responded to and assisted in donor reactions using basic first aid practices, until a medical team could respond, then documenting the event.-Calibrated the autopheresis machines each morning and repaired the autopheresis machines when they were removed from service, communicating with the manufacturer when needed.As a plasma processor:-Collected, labeled, and processed donor samples quickly and accurately to ensure the units had proper samples pulled from them, that the units remained in tact and uncontaminated, and that all was performed in the appropriate amount of time, ensuring the units were placed in the freezer within half an hour of collection.-Packed product for shipment while verifying the right units were packed and the units weren't compromised by temperature deviations or breaches in the units themselves.-Monitored freezers and stored products to ensure quality though daily, weekly, and monthly validations.-Communicated with other departments to ensure accurate documentation and quality.