Luys K

Sterility Assurance and Quality Compliance professional with 5+ years of GMP pharmaceutical and biopharmaceutical experience in aseptic manufacturing, contamination control, environmental monitoring, root cause analysis investigation, CAPA management and regulatory inspection report.

Senior Sterility Assurance Technical Writer – Global Technical Services at Minaris Advance Therapies (2021-11 – Present)

• Championed multiple continuous improvement projects, including CAPAs to reduce unfavorable QC trending data to support FDA inspection readiness, contributing to successful commercialization approval of client cell therapy product.
• SME for FDA, EMA, client, and regulatory inspections.
• Led and supported 500+ investigations involving APV/APS, EMPQ, environmental monitoring, facility events, and GMP quality systems. Including critical and major deviations
• Directed CAPA, risk assessment, and FMEA activities supporting CCS, EM programs, EMPQs, APVs, and inspection readiness.
• Partnered with global cross-functional teams to harmonize EM procedures, contamination control strategies, and quality documentation.
• Evaluated EM and quality system trends to drive risk reduction and continuous improvement.
• Authored GMP procedures, investigations, risk assessments, protocols, and technical reports.
• Mentored personnel on aseptic processing, contamination control, GMP compliance, and investigation methodologies.
• Served as acting department lead during a 3-month manager absence supporting management review committees, event triage, task assignment and assuming role as POC for all site EM/Sterility concerns question.
• Supported quality oversight and batch readiness activities for commercial and clinical cell therapy manufacturing.

QA Specialist OTF at Aerotek / AstraZeneca (2021-02 – 2021-10)

• Provide QA oversight of aseptic processing and provide real time review of batch records, logbooks, and associated GMP documentation
• Execute environmental bioburden monitoring within the Manufacturing Cleanroom
• Assist in quality investigations relating to deviations and environmental monitoring excursions
• Supported site and quality functions such as SOP revisions, internal audits, site wide projects and trending.

Lead QA Laboratory Technician at Vantage Foods (2017-05 – 2020-11)

• Train and mentor junior laboratory technicians on test methods and QA responsibilities including, but not limited to, rapid PCR testing, immunomagnetic separation, data interpretation and entry, shelf-life testing, in process product testing and day-to-day laboratory activities.
• Supported and executed real-time quality checks on the floor to ensure proper adherence to cGMP and cGDP for a large food production facility
• Became a reliable point of contact for critical quality decision regarding food product safety and product release in the absence of management during off-shift hours.

Bachelor of Science in Biology – University of Pittsburgh (2017)