GMP QC Lab Analyst and Supervisor Specialist

VITO JANCAN

Northbrook, IL ***** +1-224-***-**** ******@*****.***

QC Lab Analyst (Technician) / Laboratory Supervisor (GMP Pharmaceuticals) PROFESSIONAL SUMMARY

Quality control and laboratory Supervisor professional with 5 years of GMP pharmaceutical laboratory experience in analytical testing, sample preparation, method execution, data review, instrument troubleshooting / calibration, and laboratory operations. Proficient in HPLC, GC, UV-Vis, dissolution, wet chemistry, and OpenLab, LabX, and WinLab. Strong focus on compliance, data integrity and FDA regulated environments. Experienced in troubleshooting instrumentation, supporting laboratory investigations, and ensuring accurate and timely release testing. Known for accurate results, compliance support, and staff training. CORE QUALIFICATIONS

• GMP / GLP laboratory

operations, FDA compliance

(5 years)

• HPLC, GC, UV-Vis, dissolution

• Data integrity ALCOA+

• Laboratory investigations (OOS,

CAPA, deviations)

• Sample preparation & analytical

testing

• Result review and processing

• Instrument calibration &

troubleshooting

• Lab documentation &

compliance support (SOPs,

reports, compliance support)

• Staff training & laboratory

supervision

PROFESSIONAL EXPERIENCE

Laboratory Head Chemilab d.o.o., Ljubljana, Slovenia 09/2024 - present

(QC Analyst) Chemilab d.o.o., Ljubljana, Slovenia 09/2022 – 09/2024

• Lead daily QC laboratory operations in a GMP environment, supporting analytical testing and dependable release-related work.

• Perform and execute advanced analyses including sample preparation, analytical testing, instrument calibration, result processing, and testing using GC, HPLC, Dissolution and UV methods in compliance with SOPs and FDA guidelines

• Review analytical data to ensure accuracy and data integrity ALCOA+

• Provide technical guidance on chromatography, UV-Vis spectroscopy, wet analysis, and dissolution testing.

• Manage laboratory software and data workflows using LabX, WinLab, and OpenLab.

• Monitor reagent and consumable inventory to prevent interruptions in laboratory work.

• Prepare reports, review test outputs for accuracy, and analyze trends or anomalies in product data.

• Troubleshoot instrumentation and procedures, perform routine maintenance, and identify issues affecting test performance.

• Train and supervise laboratory personnel while reinforcing safety, equipment use, and protocol compliance.

• Participated in all routine internal, government and FDA inspections and supported the preparation of CAPA responses following inspection findings.

Change Manager Sandoz Slovenia, Ljubljana, Slovenia (Novartis) 09/2021 – 08/2022

• Supported implementation of internal and external changes in a regulated pharmaceutical environment.

• Tracked progress, documented issues and gaps, and prepared status reports for management review.

• Collaborated with cross-functional teams and senior stakeholders on process, procedure, and system changes.

• Defined success metrics, gathered stakeholder feedback, and supported change adoption.

• Delegated work and monitored the performance of project staff. EDUCATION, CERTIFICATIONS & LANGUAGES

Education University studies in Chemical Technology and Environmental Science, University of Maribor (2019 – present)

High School Diploma, High School of Environmental Science, Ljubljana (2018) Certifications GMP education certification

Advanced handling and training for GC systems

Languages Slovenian (native), English (Fluent), Serbian (Fluent), Croatian (Fluent) Tools OpenLab, LabX, WinLab, MS Office

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