Specialist QA Cover Letter

I would like to submit my application for the specialist QA opening. Please accept this letter and the attached resume.

Previously, I was responsible for qA support for Quality System cross-functional team development activities such as TrackWise enhancements for Change Control, Deviations, Investigations, Product Complaints and Supplier Quality Management.

My experience is an excellent fit for the list of requirements in this job:

• Knowledge of statistical based computer programs such as Minitab, Microsoft Office
• GMP compliance and Part 11 compliance knowledge preferred
• Experience working with software test science and tools doing software testing
• Strong Functional testing experience in BFSI domain in areas like, Wealth Management, Capital Markets, Trading & Settlement, Corporate Actions Processing, SWIFT
• Proven understanding of various testing techniques
• Strong experience in Manual Functional Testing and writing Test Cases from BRDs / FSDs
• Exposure or experience in Test Automation would be an added advantage
• Works under pressure and is able to manage competing priorities

I would like to submit my application for the specialist QA opening. Please accept this letter and the attached resume.

Previously, I was responsible for qA oversight for manufacturing and Quality System documentation including Batch Records, lot release, Change Orders, CAPA, NCRs, Deviations, etc.

My experience is an excellent fit for the list of requirements in this job:

• Working knowledge of Specification By Example
• Experience setting up automated test environments
• Microsoft Application Lifecycle Management (TFS) and Microsoft Test Manager experience
• Are not satisfied with the status quo
• Push the envelope, driving efficiencies and best practices
• Have substantial experience in requirements solicitation
• Are strong in both manual and automation testing practices
• Have a comprehensive understanding of manual testing methodology

I am excited to be applying for the position of specialist QA. Please accept this letter and the attached resume as my interest in this position.

In my previous role, I was responsible for qA support for quality system cross-functional team development activities such as TrackWise enhancements for change control, deviations, investigations, and supplier quality management.

Please consider my qualifications and experience:

• Functional knowledge of local, federal and international regulations
• Knowledge of human error awareness / prevention
• Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), Equipment Change Control (CCDB) database, ERP (SAP) and Laboratory Information Management (LIMS) systems
• Experience in material and vendor qualification, change management processes, manufacturing operations, quality operations, and/or regulatory affairs
• Previous experience with incoming material inspections, USP/EP monographs, and/or supplier management
• Collaborates with management and supervisory personnel from Operations, Quality Control and Quality Assurance to resolve problems affecting product quality
• Provide guidance and plan of action to the manufacturing floor when production events occur as defined by SOP and lead investigations of non-compliant issues according to procedures as defined by SOPs
• Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence

Please consider me for the specialist QA opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for qA input and assistance in managing unplanned event investigations, CAPA implementation and change control monitoring.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• In-depth knowledge of MFDS regulations, ISO13485 and GMP
• Strong oral and written communication in English and Korean
• Able to work, under pressure and flexible working hours based on business requirements
• Independent, proactive and able to work in a matrix environment
• Knowledge in international GMP guidelines and norms
• Analytical method development skills
• Experience in a consultative, service related or project role
• Experience with SuccessFactors or similar major LMS application an asset

I submit this application to express my sincere interest in the specialist QA position.

In the previous role, I was responsible for quality input and assistance in unplanned event investigations, CAPA implementation, SOP reviewing and change control monitoring.

Please consider my qualifications and experience:

• Fluency in Ukrainian and/or Russian
• PC proficiency in a Microsoft Windows environment
• Able to type data/use a PC for long periods of time
• Working knowledge of Bank Secrecy Act and AML Regulations, Office of Foreign Assets Control, or consumer compliance laws
• Monitoring new and existing elements of Quality to be measured
• Reviewing and tracking various structuring alerts, and cases that contain SAR’s(Suspicious Activity Reports) within the Actimize platform for the FIU team to provide coaching and timely feedback
• Composing monthly reporting metrics using the Access Database to be distributed to management
• Driving the delivery of the enhanced system design and functionality, partnering with Technology