Cayla Capocy Email & Phone Number

Phoenix, Arizona, United States

Manages both the GMP/FDA equipment validation program/team and the preventative maintenance, calibration, and repair program/team that governs all laboratory instrumentation. Manages instrumentation across multiple sites, including both R&D and production equipment. Manages a large team of validation engineers, equipment quality assurance analysts, and.

Managed the equipment validation program and validation team, which managed the validation and entire lifecycle of laboratory equipment to FDA/GMP standards. Implemented many process improvement projects across multiple domains, including creating new SOPs/processes, change control of validated instrumentation, and rolling out new software solutions..

Phoenix, Arizona, United States

Managed and trained team of validation engineers to perform a wide array of Computer Software Assurance (CSA) validation activities that span the entire validation lifecycle. Managed projects of various types, including validation, quality, and process improvement projects. Performed one-on-one meetings with personnel to help them develop and achieve.

Phoenix, Arizona, United States

Aided and managed the validation process of laboratory instrumentation throughout the entire lifecycle of the equipment. Created and executed qualification/Computer System Validation (CSV) deliverables for computerized software laboratory systems following GMP/GAMP5 guidelines. Organized and coordinated with laboratory personnel to perform system.

Maintained regulatory compliance to all applicable regulatory requirements (CLIA, NYS, CAP, ISO, FDA, IVDD, etc.). Participated in internal and external audits. Managed company records in accordance with regulatory requirements and company policies. Authored, reviewed, revised, and implemented standard operating procedures (SOPs) for the QMS. Compiled and.

Performed high-complexity molecular diagnostic testing on patient samples, testing for viral and bacterial infections using DNA extraction and qPCR on the Rocha MagNA Pure and QuantStudio 7 platforms. Aided in bringing up COVID testing on the QuantStudio 7 and Hamilton STAR platforms, performing instrument validations for qPCR detection of COVID-19. Served.

Phoenix, Arizona Area

Performed instrument IQs, OQs, PQs, and validations to prepare for FDA submission. Created and edited SOPs, training documentation, and training presentations for proprietary instrumentation and methods based on Illumina HTS assay. Performed manual and automated DNA extraction and hybridization of DNA onto Illumina BeadChips for genetic marker testing..

Phoenix, Arizona Area

Did high-complexity manual and automated testing on donor blood samples using Abbott PRISM, ASiManager, QuickStep, Hamilton STAR, Cobas Ampliprep, and Sebia Capillarys SPE testing platforms. Performed instrument validations, quality control, calibration, sample management, result reporting, troubleshooting, lot changes and lot qualifications. Worked with.