Quality Specialist Senior Cover Letter

In response to your job posting for quality specialist senior, I am including this letter and my resume for your review.

In the previous role, I was responsible for oversight of aseptic operations, including supporting Quality Assurance (QA) on the floor team to observe aseptic processing, including media fills to meet US and international aseptic processing requirements.

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:

• Trains other laboratory analysts in the use of laboratory equipment and execution of analytical methods
• Leads and facilitates the verification of compendia analytical methods
• Assists QC Supervisor, Chemistry in the establishment of Laboratory Information Management System (LIMS)
• Experience with Gas Chromatograph (GC), High Pressure Liquid Chromatography (HPLC) and UV/Vis Spectrophotometer
• Bachelor Science in Science, Engineering, or Business
• Understanding of FDA regulations/guidance as related to change management and supplier management
• Experience working with customers understanding concerns and challenges while applying regulatory compliance and company policy guidance and maintaining excellent relationships
• Good knowledge of quality / compliance management regulations and standards affecting APIs and Biologics

In response to your job posting for quality specialist senior, I am including this letter and my resume for your review.

Previously, I was responsible for qA support to new product registrations for R&D Audit assigned efficacy, safety, validation, bioanalytical for compliance with US and EU regulatory directives.

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:

• MA in health care or related field
• Attention to detail and able to work efficiently to meet deadlines and timelines
• Experience in an FDA regulated industry (medical device, pharmaceutical, ) is preferred
• Experience using MS Project, including preparation of critical path analysis and Gantt charts, is preferred
• Background in developing, customizing and/or implementing interrelational database applications, especially for project tracking or facilitating virtual work groups (SQL, Cognos, Access, Encore, Sharepoint, Wiki )
• American Society for Quality (ASQ) CQE, CQA, CMQ/OE, CSSGBB, CSSBB, or equivalent professional credential is preferred
• Certified Professional Coder (CPC) or Medical Record Review experience preferred
• Demonstrated verbal, written and formal presentation skills

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

Previously, I was responsible for support to R&D in compilations of the Chemistry and Manufacturing Controls (CMC) sections of regulatory submissions;.

Please consider my qualifications and experience:

• Assist with developing training presentations for the complaint handling database and systems
• Create reports extracting complaint data out of the complaint handling database
• Create customer response letters upon request
• Support internal and external audits/inspections
• Experience with MDRs and/or MDV’s is an asset
• Experience with failure analysis and root cause determination is preferred
• Project management and/or project leadership abilities are an asset
• Working knowledge of quality system requirements (QSR), ISO 13485 and Risk Management ISO 14971 is preferred

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

In the previous role, I was responsible for input to our Quality Assurance and Regulatory Affairs departments for the processing of reportable events to regulatory agencies worldwide.

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:

• ASQ (American Society for Quality) certifications are preferred
• Demonstrated QA system experience (investigation, CAPAs, change controls, validation)
• QC experience preferred
• Knowledge of Value Stream processes (Device, Drug, Cosmetic )
• Communication with all levels of operations
• Or has demonstrated competency in acceptable Product Release as evidenced by external compliance audit
• Lean Six Sigma Yellow Belt or suitable alternative
• Qualified Auditor (desirable)

In response to your job posting for quality specialist senior, I am including this letter and my resume for your review.

Previously, I was responsible for hygienic design expertise for utilities and manufacturing systems with a focus on aseptic operations, bioburden control, and cleanability.

Please consider my experience and qualifications for this position:

• Experience with testing automation tools, , Selenium/WebDriver
• Experience working in a containerized (e.g., Docker, rkt, ) cloud environment
• Established role of a Quality Expert, with a strong technical background and competencies, and a track record of individual technical accomplishments
• Production, manufacturing or QA experience
• Technical, traditional or military education
• Exposure to 6 Sigma or Lean environment
• Prefer TQM certification (Total Quality Management Certificate)
• Computer skills - Microsoft Word, PowerPoint, Excel