Catherine Williams, Phd Email & Phone Number

Brentwood, Tn, Us

Brentwood, Tn

At Cairn Diagnostics, the manufacturer and distributor of the 13C-Spirulina Gastric Emptying Breath Test (GEBT), I have undertaken a broad range of critical functions. These include overseeing laboratory operations, authoring regulatory submissions, and developing essential documents such as standard operating procedures and product specifications. I have also facilitated communication with third-party clinical trial clients and led both client and employee training programs. My… Show more At Cairn Diagnostics, the manufacturer and distributor of the 13C-Spirulina Gastric Emptying Breath Test (GEBT), I have undertaken a broad range of critical functions. These include overseeing laboratory operations, authoring regulatory submissions, and developing essential documents such as standard operating procedures and product specifications. I have also facilitated communication with third-party clinical trial clients and led both client and employee training programs. My responsibilities have extended to the validation of instruments for clinical use and ensuring compliance with Quality Systems Regulations, ISO 13485, and clinical laboratory standards. This work encompasses process and analytical validations, product development, design controls, and the interpretation and analysis of clinical data.I have additionally served as interim Director of Quality Assurance during key staff transitions, overseeing the company’s quality systems and regulatory compliance efforts. As the principal investigator for Cairn-sponsored clinical studies, I contribute to advancing product offerings and expanding clinical applications. Show less

Brentwood, Tn

Since 2021, I have assumed leadership of Cairn’s clinical laboratory, the sole facility authorized to analyze 13CO2 breath samples for the GEBT. In this role, I authored the Clinical Laboratory Quality Manual, oversee all laboratory operations, manage proficiency testing programs, maintain licensing, and ensure full compliance with federal and state regulatory requirements.

Brentwood,Tn

Sample analysis, analytical method development and validation, quality control, stable isotope mass spectrometry, statistical analysis of clinical data, writing and reviewing protocols, standard operating procedures, PMA submission to FDA, cGMPs, OOS, Deviation reporting and CAPAs, 21 CFR 820, 21 CFR 210/211, 21 CFR 4, 21 CFR 11, 21 CFR 803.

Nashville, Tn

Analyzed pesticides in water, soil, vegetation samples using GC-MS, LC-MS, ELISA techniques. Position included sample accessioning, method development.

Mount Juliet, Tn

Trace metals analyst

New Brunswick, New Jersey

Postdoc fellow for Prof Rich Lutz: hydrothermal vent ecology.

Doctor Of Philosophy - Phd, Oceanography, Biochemistry

Master Of Science (Msc), Oceanography - Chemistry Focus

Bachelor Of Science - Bs, Chemistry, Hons