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 equipment quality assurance associates across both programs and a wide array of tasks and job functions. Leads many process improvement projects and overhauls of processes to prepare for FDA and ISO certifications. Serves as SME for many software platforms and internal processes.

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. Served as SME for many platforms, including the electronic validation lifecycle management system (eVLMS) ValGenesis, the computerized maintenance management system (CMMS) eMaintenance, and electronic quality management system (QMS) Dot Compliance. Worked collaboratively with interdepartmental leadership to manage the validation lifecycle of laboratory systems from commissioning through retirement.

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 professional goals, keep open communication lines, and improve relationships. Worked collaboratively with interdepartmental teams to manage the validation lifecycle of laboratory systems. Worked with team to implement multiple processes and programs, including electronic validation management systems (ValGenesis), project management solutions (Jira, Confluence), and equipment inventories.

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 qualifications/validation activities. Managed changes to GMP validated systems via change control to keep systems regulated. Used Microsoft Project and Office regularly to manage project statuses, update timelines, and identify stakeholders. Created and revised SOPs for various processes using MasterControl QMS, including system administration SOPs, validation SOPs, and use and maintenance SOPs.

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 QA review of various laboratory instrumentation qualifications such as NovaSeq performance qualifications (PQs). Compiled and performed QA review for various laboratory assay validations such as IHC antibodies. Compiled and performed QA review for instrumentation cross correlations for the Illumina NovaSeq, Promega GloMax, Thermo Fisher Qubit, and ABI 7500 systems.

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 as SME for the Hamilton STAR, MagNA Pure, and QuantStudio platforms. Trained multiple technologists and students on the bench and general laboratory procedures, aseptic technique, and correct use of equipment. Used LIMS and document control system MasterControl to enter and release results, stay current on training, and track pending samples that needed testing.

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. Worked closely with a team, as well as independently, on large projects to get lab up and running. Ran and did troubleshooting on a variety of instrumentation, both manually and with robotic automation, including Hamilton STAR, Liconic incubator, Lunatic plate reader, Kingfisher Presto, Tecan Freedom EVO, and Illumina iScan. Used Google Suite and MS Excel extensively to create spreadsheets for inventory management, quantification data collection, and training documentation. Lab was closed down due to company restructuring.

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 customers to provide results and quality customer service via phone and email. Used 6S and Kaizens to improve workflow, save time, and increase efficiency in lab.