Peter Lococo, Mph Email & Phone Number

San Diego Metropolitan Area

San Diego, California, United States

• Provided technical and operational leadership for new product introduction (NPI) and increased quality and yield in production environments while serving a critical role within the Product Development Process (PDP)
• Developed and optimized functional library preparation assays, NGS platform test methods, and validation activities to ensure the successful technology transfer into the Functional QC department by liaising with R&D.
• Established functional QC specifications to meet product specifications through cross-collaboration with R&D and engineering operations
• Successfully conducted investigations and performed root cause analysis/troubleshooting
• Supported COG’s reduction by leading a cost savings study while conducting wet-laboratory work and executing test methods
• Led routine meetings with functional QC department representatives that involve the planning and execution of RQC Test Method Development and Validation Experiments

San Diego, California, United States

Carlsbad, California, United States

• Played an active role in expanding the clinical claims of the Ion TorrentTM OncomineTM Dx Target Test (ODxTT) to specific DNA hotspots & RNA fusions for future FDA submissions
• Delivered full proficiency training to internal and external operators for the ODxTT workflow
• Served as point of contact in charge of operator resource allocation, experiment planning, sample and reagent procurement, study timeline generation & adherence, etc
• Provided operator run failure repeat strategies and planning, presentation of data at group and stakeholder meetings, final data analysis, study protocol, and report authoring
• Offered Site Initiation Visit training to external operators participating in specific AV&V studies at Clinical Research Organizations (CROs)

Carlsbad, California, United States

Poway, California, United States

• Oversaw all complete quality inspections on finished products before distribution for this manufacturer of in vitro diagnostic assay (IVD) medical devices utilized in product development as well as raw material.
• Gained exposure of UN’s globalized harmonized system while authoring safety data (SDS) sheets for finished products for OSHA compliance (working knowledge of ExESS software)
• Optimized and validated assay parameters for various chemistry analyzers while working with global medical device distributors and end users
• Ensured each vendor met the minimum standards; products met/maintained GMP requirements and quality assurance by tracking approved raw materials suppliers/vendors
• Tracked suppliers and vendors to ensure SOPs were maintained, including analyzing, maintaining, and tracking non-conforming materials reports

Master Of Public Health - Mph, Epidemiology

Bachelor Of Science - Bs, Biology/Biological Sciences, General