ANDREW T. ZAPOTOSKY
Bensalem,PA
Summary
GMP analytical professional with 10 years of experience spanning pharmaceutical/biopharmaceutical QC, analytical testing, laboratory operations, and validation. Experienced in execution of validated analytical methods, GMP stability testing, data review, sample preparation, laboratory investigations, and validation activities within regulated environments. Strong hands-on experience with HPLC, GC-MS, LC-MS, ICP-MS, CE-SDS, and Karl Fischer. Experienced with GMP/GLP documentation, ALCOA+ data integrity, deviations, CAPA, change control, and TrackWise. Background supporting pharmaceutical manufacturing and analytical operations, including experience with Merck and Abzena.
Overview
10
10
years of professional experience
Work History
Analyst
Green Analytics
Mercerville, NJ
02.2025 - Current
- Conduct high-throughput sample preparation and analytical testing using validated methods to ensure compliance in regulated laboratory environment.
- Operate HPLC, GC-MS, LC-MS, ICP-MS, and automated liquid-handling systems for routine analytical testing.
- Execute testing in accordance with GMP requirements, approved SOPs, and established analytical procedures.
- Maintain accurate, complete, and traceable analytical records in accordance with ALCOA+ data integrity principles.
- Facilitate laboratory workflow and manage sample throughput to ensure timely completion of analytical testing in high-volume environment.
- Detect and report analytical or procedural issues to maintain adherence to established laboratory and quality procedures.
QC Associate, Analytical
Abzena
Bristol, PA
10.2023 - 02.2025
- Executed validated analytical methods including HPLC, CE-SDS, and Karl Fischer.
- Executed validated analytical methods HPLC, CE-SDS, and Karl Fischer to ensure reliable test results for ADC products.
- Performed analytical sample preparation, testing, documentation, and review in accordance with GMP procedures and approved methods.
- Conducted analytical data review to ensure accuracy, completeness, and compliance with GMP and data integrity standards.
- Maintained GMP documentation and sample traceability to support regulatory compliance and facilitate efficient testing processes.
- Supported timely execution of QC testing within a regulated biopharmaceutical environment.
Senior Engineer
CBRE at Merck
West Point, PA
11.2016 - 03.2021
- Executed cleaning validation protocols, ensuring compliance with acceptance criteria through swab and rinse sampling.
- Performed analytical testing associated with cleaning validation, including recovery studies, residue analysis, and gravimetric methods.
- Executed cleaning validation protocols, including swab and rinse sampling and verification of established acceptance criteria.
- Authored, reviewed, and maintained validation protocols, reports, and associated GMP documentation.
- Investigated deviations and supported root-cause analysis and CAPA activities using TrackWise.
- Supported implementation and monitoring of corrective and preventive actions within established quality systems.
- Collaborated with laboratory, manufacturing, engineering, and quality personnel to ensure adherence to validated processes and GMP requirements.
Education
Bachelor of Science - Biology
Pennsylvania State University
Skills
- GMP / GLP Analytical Testing
- Pharmaceutical & Biopharmaceutical QC
- Analytical Method Execution
- Stability Testing
- HPLC / GC-MS / LC-MS
- ICP-MS / CE-SDS / Karl Fischer
- Sample Preparation & Laboratory Operations
- Data Review & Data Integrity / ALCOA
- Deviations & CAPA
- Root Cause Analysis & Investigations
- Cleaning Validation
- IQ / OQ / PQ
- Validation Protocol Execution
- GMP Documentation & SOP Compliance
- Change Control
- Laboratory Systems & LIMS
- Analytical: HPLC, GC-MS, LC-MS, ICP-MS, CE-SDS, Karl Fischer, automated liquid handling
- Quality / Validation: GMP, GLP, ALCOA, deviations, CAPA, change control, cleaning validation, IQ/OQ/PQ, validation protocols, investigations
- Systems: Empower, LabWare LIMS (Labworks), TrackWise, Microsoft Excel
Personal Information
Title: GMP QC / ANALYTICAL SCIENTIST
Timeline
Analyst
Green Analytics
02.2025 - Current
QC Associate, Analytical
Abzena
10.2023 - 02.2025
Senior Engineer
CBRE at Merck
11.2016 - 03.2021
Bachelor of Science - Biology
Pennsylvania State University