Quality Systems Analyst Cover Letter

I would like to submit my application for the quality systems analyst opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for direction to ensure compliance with all applicable customer requirements, government regulations, and ISO standards.

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:

• Familiarity with programming languages, such as SQL
• Both hands and legs
• Hearing at conversation level
• Experience with Oracle applications, QAD applications, Minitab, and MicroStrategy report writing is essential
• Experience developing statistical based reports is necessary
• Experience with supporting quality system procedures and policies in compliance with 21 CFR 820, ISO 13485 20XX, EN46000, 93/42EEC, and other applicable regulations is preferred
• Working knowledge of MS Office applications is necessary
• Analytical thinker with an organized approach to reporting and business improvement

I would like to submit my application for the quality systems analyst opening. Please accept this letter and the attached resume.

Previously, I was responsible for site input to the J&J representatives of industry and standards associations (e.g., AAMI, ISO, AORN), influencing regulations and standards.

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

• Familiar with standard quality processes (corrective action, root cause analysis)
• A demonstrated proficiency in the interpretation and application of computer system-related GxP requirements (e.g., 21 CFR Part 11)
• Previous experience in development or management of quality systems
• Proficiency in industry standard software applications such as the MS Office suite
• Communication, interpersonal, and organizational skills are essential
• Solid written and verbal communication and organizational skills
• Advanced skill set specifically with Microsoft Excel and generally other MS Office applications
• Knowledge of FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803 and 820)

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

In the previous role, I was responsible for site support on quality system issues to ensure adherence to ISO, FDA, CMDR, IVDD, J-PAL and any applicable regulations as well as BCI requirements and industry best practice.

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

• Work independently and/or as a member of a small team to conduct research and develop reporting tools to assist in business decisions
• Possess a positive “can-do” work attitude, passionate, motivated and strong willingness to learn
• Active team player who can take direction but also willing to provide input and ideas
• Understanding of data management and applications within the SAP environment, specifically Business Intelligence
• Basic knowledge of quality assurance and regulatory compliance in the food industry
• Knowledge of software development lifecycles-specifically Agile Methodology
• Knowledge and experience working with HACCP Programs and other Food Safety pre-requisite programs
• Working knowledge of statistics such as Z scores is preferred

I would like to submit my application for the quality systems analyst opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for core support for Product Labeling electronic files used to create NeuMoDx product labeling, with input from Regulatory Affairs, and in compliance with FDA regulations and ISO standards.

Please consider my qualifications and experience:

• Good knowledge of all quality system programs, including HACCP, Food Safety, Sanitation, Allergens, and how these programs integrate with other plant operations
• Experience with a full scale implementation of a of Quality applications including all phases (blueprinting, gap analysis, system design, configuration, testing, training, and go-live support)
• Skilled in writing functional / technical specifications with detail explanation of completed design
• Experience in testing and supporting custom developments
• Experience with computerized systems validation, GXP assessments, and/or change management
• Participate in a leadership role for project related to new module introduction, roll out to new regions and blueprint gap analysis
• Spokesperson for functional area
• Technical and scientific expert for functional area, can interact effectively with product and process engineers and engineering managers

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

In the previous role, I was responsible for quality support and services to Clinical Supplies (Operations and Clinical Services Unit), as needed, to ensure compliance to cGMP and other applicable regulations.

Please consider my experience and qualifications for this position:

• Knowledge and application of computer systems for word processing, complaint management, and trending
• Experience with OBIEE analytics
• Knowledge of Trackwise and Agile Quality application preferred
• Working knowledge of Agile PLM 9 preferred
• Knowledge/experience with using Oracle Application Tables, SQL, PL/SQL preferred
• Blueprint reading and GD&T preferred
• Proficiency in company computer software systems (AS400), MS Office, and HYG Berea Management Quality System, NOMS, CORE, EDM Fusion Pro
• Minimal experience in Application development and delivery environment preferred