Specialist Ii Document Control

Vukica Porobic

QA Specialist II

619-***-**** ********@*****.***

Seven plus(7+) years of excellence and working knowledge of GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and ISO 13485 from an early stage to clinical medical device phase. Thorough understanding and implementation of QMS requirements. Agile and versatile in translating cross-functional teams to results driven quality process improvements. Passionate about Quality needs and proficient in quality implementation. Core competencies: GMP/GLP, Quality Audit, Document Control, Compliance, Deviations and CAPAs. Work Experience

QA Specialist II, HD BioSciences, a WuXi AppTec Company Aug 2021 - Present

• Oversight of company QMS via SOPs, Quality Training, GDocP, QDIP and System Maintenance.

• Developed company wide platform software systems for training, scientific testing, shipping and receiving, and deviations ticketing system.

• Manage QA document control functions, review documents, and implement quality.

• Planning, preparation, and lead of internal and client’s audits.

• Manage CAPA activities.

• Collaborate with EHS to implement company safety policies. QA Associate/ii, Catalent Inc. Sep 2017 - Oct 2020

• Responsible for review of analytical in-process, release, stability data packets.

• Reviewed and maintained manufacturing batch records and supplier testing and investigations.

• Facilitated deviation documents analysis, risk assessment and approval.

• Conducted manufacturing activities including but not limited to audits, line clearance, label quarantine/release, cleaning verification review, and raw material release data review.

Jun 2015 - Jan 2017

• Researched nouvelle drug development and stability experiments using HPLC with UV,VIS, PDA and ELSD detectors.

• Executed analytical procedures to assess the quality of pharmaceutical API (active pharmaceutical ingredient), intermediates, and final drug products under limited supervision.

• Conducted robust QC laboratory tests in compliance with internal Standard Test Methods, compendial methods, utilizing the following instruments: HPLC, HORIBA Particle Size Analyzer, HIAC/ROYCO Sizing Counter, Osmometer, etc.

• Responsible for performing laboratory investigations, troubleshooting and writing reports as required.

• Provided training to other laboratory personnel. Science Teacher, British International School, Ticehurst Cambridge School of Belgrade, Serbia Apr 2014 - May 2015

• Chemistry and Science teacher. Taught to Year 7 through Year 13 Dec 2010 - Nov 2013

• Conduct and analyze raw and in-process materials testing in support of GMP products in a fast paced medical device environment. SDS-Page separation, IgG Purity Analysis, capillary isoelectric focusing (cIEF).

• Perform testing of highly precise DNA sizing on the CEQ Genetic Analysis System to test the functional acceptability of capillary array and various DNA products.

• Ensure appropriate maintenance of all quality records and device history records using EDMS and Oracle software.

• Cross trained in technical operations: CAPA, DR, and Investigations. Skills

CAPA, Audit Planning, Quality Training, QDIP

Education

Bachelor of Science in Chemistry Chemistry Sep 2007 - May 2010 San Diego State University - San Diego, CA

Chemistry Department – Bioanalytical Separations Dec 2009 - Sep 2010 San Diego State University - San Diego, CA

Certifications

Kaiser Perm Program Certified

GLP for the clinical studies CPIE award

PRESENTATIONS AND PUBLICATIONS

Christopher R. Harrison, Jack Chuan-Yu Fang, Kimberly J. Walthall, Chelsea C. Green, Vukica Porobic.(2014). “Towards the identification of autol- ogous blood transfusions through capillary electrophoresis,” Analytical and Bioanalytical Chemistry, 406, 679-686.PITTCON Pittsburgh Conference

(2011) – Capillary Electrophoretic Determination of Erythrocyte Aging, a tool to detect blood doping. WCBSUR Conference at Point Loma University

(2011).

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