Chea B. Kunwon

18 Brookside Drive Apt D. Clifton, NJ 07012 Ckunwon@gmail.com

PROFESSIONAL SUMMARY:

Fulfilled roles as a seasoned Quality Assurance professional within pharmaceutical industry with expertise in Quality Assurance as stated in my resume

Served as experienced Quality Analyst working seamlessly and in tandem with process improvement teams to remove waste during batch record processing, distribution of products and manufacturing of client products.

Implemented and managed Plateau’s/Success factor Electronic Learning Management System (LMS) within very short time frame (14 days).

Served as reputable trainer throughout organization adept in coaching and delivering on high priority projects

Continuous Improvement methodologies for profitability.

Coached more than 3,000 employees on International Conference Harmonization (ICH), Federal Drug Administrative (FDA) directives and current Good Manufacturing Practices (cGMP) guidelines.

Quick study in collaboration with cross-functional teams to prepare, organize and respond to internal audits.

Developed, reviewed, revised, and monitored Standard Operating Procedures (SOPs), training and knowledge assessments, forms, and Work Instructions (WI).

PROFESSIONAL WORK EXPERIENCE: Valeant Pharmaceuticals International, Bridgewater, NJ April 2016 - Present External Manufacturing Product Release Specialist (Contract ended September 2016) Performance high priority Quality Assurance work as assigned

Release pharmaceutical and Over-the-Counter (OTC) product in compliance with 21 CFR 210 and 211.

Addressed and documented Non-Conformance (NC) and Deviations

Managed External Manufacturers (CMO, EMO) for pharmaceutical products

Created Change Controls (CC) to document changes Novartis Consumer Health (Contract) Parsippany, NJ Oct 2015 – Jan 2016 Compliance Associate (Contract ended due to site closure in 2016) Performed Compliance related responsibilities as directed by Head of Drug Safety and Pharmacovigilence • Request, QC, Track and resolve discrepancies regarding Periodic Safety Update Reports (PSURs) • Create Metrics for PSURs and Learning Management System training as directed • Investigate and close open cases utilizing drug safety databases • Overview understanding of Pharmacovigilence System Master File (PSMF) • Overview understanding of Drug Safety Pharmacovigilence Teva Pharmaceuticals USA, Inc. (Contract ended due to site transfer) May 2015 – June 2015 Learning Management System/Quality Assurance • Issuance of log books to Scientist and other personnel as required • Quality Assurance Contractor for administration of the electronic Learning Management Systems. Setting up new users,

creating training items and curricula, answering questions. • Worked with computer in the electronic training management system, remaining time mostly performing document

archive duties such as document receipt, archiving, scanning and tracking • The face of training for personnel moving from Rockville, Maryland Site and GMP Archivist. Shire Pharmaceutical, Plc (Contract ended due to new head quarter transfer) Oct 2014 – Dec 2014 Clinical Development Compliance & Training Specialist Managed Global Clinical Development training coordination activities and assisted Clinical Liaisons with smooth work flow.

Monitored Clinical Development and Training Mailbox and responded to 300+ emails monthly.

Managed Clinical Development and Training Metrics and tracked 100% of all training and records for compliance purposes.

Utilized Microsoft Excel spread sheet to track 100% of the new hires, Leavers, and Leave-of-absence personnel for Shire’s Research and Development (R&D) department.

Successfully completed five specials projects; each project had a minimum of 1000 data for sorting and distribution to various stakeholders.

Impax Laboratories Inc., Philadelphia, Pa (Contract) June 2014 – July 2014 QA Batch Record Reviewer

Responsible for evaluating documentations for bulk drug products for release and further processing and perform disposition activities

Addressed and resolved any discrepancies found during review.

Independently review and/or approve GMP documentation related to sterile drug product manufacturing, ensuring compliance with company and regulatory standards.

Generated/approved COCs or COAs and issued COMR for third party products.

Performed release transaction in SAP and associated material movement and disposition.

Evaluated documentation required for disposition of raw materials and components for use in manufacturing and perform disposition activities.

• Support review and approval of analytical documentation in support of product release and dating extensions

• Assisted with the preparation of Annual Product Review reports and retain sample inspections. Fisher Clinical Services, Thermo Fisher Scientific, Bristol PA & Allentown, PA 2008-2011 Quality Assurance Specialist (Oct 2011 – Feb 2013) Implemented and Managed the Learning Management System (LMS), successfully led new hire orientations and training and contributed to Process Improvement activities for profitability and growth.

Reviewed, determine batch record disposition, and addressed/resolved any discrepancies with accuracy rating of 98% Right-First-Time (RFT).

Supported event and deviation investigations from a quality perspective, provided reviews, guidance and approvals; also review and work with operations areas of CAPAs.

Drafted, assessed and reviewed operations, distribution, and packaging change controls for approval by various department heads.

Led several employees that performed various activities in the organization to ensure continuous improvement by direct observation to perform task in a timely manner

Provided direction and training of staff on new systems, procedures and activities

Collaborated with cross-functional teams to identify effective corrective and preventive actions to improve process quality

Can conduct root cause analysis for compounding errors and processing errors generated at the facility during all phases of the production process.

Developed, reviewed, and revised 100% of Quality Policies, Standard Operating Procedures (SOPs), Change Controls, forms, and Work Instructions (WI).

Implemented Plateaus’ Learning Management System (LMS) for Bristol facility which eventually removed over $95,000 in paper waste and added productive training from paper to electronic for all employees.

Instructed employees on Federal Drug Administration (FDA), current Good Manufacturing Practices (cGMP) regulations and Quality practices during weekly new hire orientation.

A reputable trainer throughout organization adept to delivering training to applicable teams in an organization.

Experienced working closely with appropriate ThermoFisher organizational management teams on site level to continuously improve strategies of effective business needs.

Led daily Quality Assurance department GEMBA stand up meetings and possessed detailed GEMBA board skills.

Accomplish in composing, reviewing, and revising reports (when necessary), for Global Operations metrics as well as facilitate this process at the site level.

Quality Assurance Inspector (Jul 2008 – Oct 2011)

Performed Quality Assurance Inspection activities related to incoming materials, production, distribution, labeling, auditing and reconciliation (destruction) and supported other quality assurance departments.

Responsible for daily quality operations within the logistics department and ensure compliance to procedures and addresses non-compliance issues

Performed internal audits of processes, systems and procedures

Inspected/verified 50% of the total annual client shipments for adherence to Federal Drug Administration (FDA) standards, current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP) guidelines.

Tracked 100% of errors found during Quality verification for improvement and training purposes in Microsoft Access data base.

Crossed-trained to support incoming inspection, manufacturing, and label control. EDUCATION Philadelphia University, Philadelphia, PA.; May/2012 graduated Degree: Bachelor of Science; Major: Health Science TRAINING & CERTIFICATION: • 2010 – Continuous Improvement Facilitator Certification, Fisher; 32 hours. • 2011 – Plateaus/Success factor Learning Management System Administrator Certification, Fisher Clinical Services, Thermo

Fisher Scientific; 32 hours. • 2013 – Train the Trainer Certification, Thermo Fisher Scientific; 24 hours. • 2013 – Continuous Improvement Process Manager Certification, Thermo Fisher Scientific; 40 hours. HONORS & AWARDS:

2009 – Recognition Award for outstanding performance, Fisher Clinical Services, Bristol.

2010 – Quality Assurance Person-of-the-Year; Fisher Clinical Services, Bristol.

2011 – Annual Impact Award for Implementation of the Success Factor’s Electronic Learning Management System (LMS); Fisher Clinical Services, Thermo Fisher Scientific.

2011 – Promoted from Quality Inspector to Quality Specialist; Thermo Fisher.

2013 – Co-Implemented and managed the “STAR” initiative; ideas for concrete improvements. COMPETENCIES: Quality Assurance, current Good Manufacturing Practices (cGMP), Attention-To-Detail, Written/Verbal/Interpersonal Communications, Quality Management Systems, Special Projects, Compliance, Standard Operating Procedure (SOP), Collaboration, Problem Solving, Analysis/Research Skills, Micro Soft Office, Technical Documentation, Public Speaking/Presentation, Continuous Improvement, Internal Audits, Drug Enforcement Administration (DEA) Standards and Policies, Root Cause Analysis, data-driven decision making; strong risk analysis, Strong Quality Regulation, Computer skills