QA Compliance Cover Letter

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

In my previous role, I was responsible for on-the-floor QA oversight in GMP cleanroom and laboratory environments and support to ensure compliance to GMP regulations throughout those areas.

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

• Adopt the “Beyond Compliance Quality Culture” in the work environment
• Experience with reading and verifying P&IDs, process flow diagrams, system drawings
• Thorough knowledge of mobile and desktop operating systems
• Combination Product and Device QMS and regulatory knowledge/experience
• Previous pharmaceutical industry with a focus on Microbiology is preferred
• Team Leadership (demonstrates effective knowledge and credibility to lead projects and training team colleagues whether falling under direct reporting structure or not)
• Evaluation (implementation of various evaluation levels ranging from reaction and response to training to evaluation of skills and learning to job environment and company culture)
• Computer proficiency in Microsoft Word, Excel, Outlook, and PowerPoint related programs necessary to produce training outcomes

In response to your job posting for QA compliance, I am including this letter and my resume for your review.

In my previous role, I was responsible for on-the-floor” manufacturing support and participate in routine production walkthroughs and lead self -inspection activities related to systems, data integrity, and GMP compliance.

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

• MS Office applications and Track Wise
• Thorough knowledge of best practices in quality management in pharma, medical device and combination products
• Thorough knowledge of aseptic processing and sterile drug products
• Expert understanding of the market and industry regarding Quality
• Extensive cGMP QA programs
• Proven experience interfacing with regulatory authorities, notified third party audits and either leading or being in a lead role
• Adeptness at creating and communicating a clear vision among direct reports, effectively aligning resources and motivating teams to achieve goals
• Technical and business knowledge of diverse areas including product development and clinical research processes

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

Previously, I was responsible for qA oversight for on-floor surveillance of development GMP batch processing as needed and for other applicable quality related events.

Please consider my qualifications and experience:

• Previous experience with vaccines
• Previous working experience in a regulated environment (GxP, preferably GLP)
• Familiarity with Laboratory Information Management System (preferably Watson LIMS)
• Knowledge of immunoassays, electrochemiluminescent methods on the Meso Scale Discovery platform, and cell-based assays
• English fluent in speaking and writing, second language desirable
• Sound administrative and computer skills are necessary including MS Office Suite
• Experience maintaining compliance around a Customer’s quality systems and ensuring that processes, tools, controls, and KPIs are being managed
• Experience assisting in the development of additional quality/compliance processes, tools, controls, and KPIs that are needed to supplement those of the Customer

In response to your job posting for QA compliance, I am including this letter and my resume for your review.

In my previous role, I was responsible for quality & SME technical guidance to sites, CMOs and LOCs to minimize GMP and product quality compliance risks.

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

• Experience monitoring, tracking and reporting on non-conformances, corrective actions, and Risk Management
• Experience in business writing- drafting process, Key Performance Indicators (KPIs), Procedures, Work Instructions, Knowledge Articles, and training materials
• Knowledge of Quality management system meeting the requirements of ISO 9001
• Knowledge of Quality Assurance practices in Service Desk and Desktop Services environments
• Knowledge of Training, Change/Configuration Management, Incident/Problem Management, Document Control/Retention, Business Continuity/Disaster Recovery, Business Relationship/Service Level Management, and Physical/Logical Security best practices
• Strong communications skills (listening, speaking, and writing)
• Able to work well in a global and dynamic work environment
• Expertise and comprehensive understanding of GMP including 21 CFR Part 4, 210/211, 820 ICH guidelines

In response to your job posting for QA compliance, I am including this letter and my resume for your review.

Previously, I was responsible for direct Quality Assurance support for all GMP activities (including on-the-floor quality oversight, deviations, change control and CAPAs).

Please consider my qualifications and experience:

• Strong background in developing quality objectives through effective quality planning
• Medical Devices is preferred
• Solid understanding of medical device design control and regulations quality management standards (ISO 13485, 21 CFR part 820, EU Medical regulations, Canadian Medical Device regulation, MHLW M.O
• Solid experience in Risk Management (ISO 14971)
• Knowledge of international standards requirements according to IEC 60601, 62304, 62366, ISO 14457
• Experience in supporting preparation of 510k/PMA submissions, EU Technical File compilation and other ROW product registration
• Quality agreement preparation
• Knowledge of dental environment is preferred