QA Specialist / Senior Specialist Cover Letter

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

In my previous role, I was responsible for change request (CR) intake and validation support, participate in testing activities, and assist with Release Management activities.

Please consider my qualifications and experience:

• Accountable to propose and ensure implementation of actions to achieve or maintain the in use status of the quality standards taking into account the quality requirements and the cost awareness
• Communicate outcomes of the audits related to significant quality or compliance issues to internal
• Provide guidance, advice, and support for GMP Quality Compliance matters
• Support filings and submissions as requested by the local PTR representative
• Create / maintain / upload the internal audit tracking spreadsheet (data base) and mange it with real time data
• Database familiarity with data entry/searches / queries, • Excellent organisational & planning skills, • IT literate - MS Office – Word, Explorer, Excel, Access, Outlook, • Previous QMS process design, implementation, management and utilisation experience, • Significant Scientific/GXP Knowledge
• Experience with full implementation of QA program requirements in an EPC and operational environment
• Thorough knowledge and experience in corrective action program implementation, causal analysis, and trend analysis

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

In my previous role, I was responsible for quality review and approval of all investigations, deviations, change controls, validation protocol and reports (IQ/OQ/PQs), SOPs, and in-process controls in support of manufacturing.

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

• Proven experience in a multi-national company with a matrix reporting structure
• Solid understanding of quality management system
• Tenacity in following through on details
• Knowledge of quality assurance, quality control and configuration management methodology and techniques
• Working knowledge in a QA team in knowledge in system design, hardware design, software development, and testing
• Excellent leadership and interpersonal skills, including collaboration, communication and training skills organizational skills and attention to detail
• Auditing or comparable experience
• Advanced/In-depth knowledge of relevant regulations and guidances

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

Previously, I was responsible for quality review of investigations, deviations, change controls, validation protocol and reports (IQ/OQ/PQs), SOPs, and in-process controls in support of manufacturing.

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

• Working knowledge and understanding of GLP and GCP regulations
• Work with Product and Development teams to develop and review test plans for coverage, efficiency, and effectiveness
• Create, maintain and execute automated and manual tests for workflow, web services, and user interfaces
• Analyze defects found during testing to identify likely root cause, and document and communicate findings for further action
• Monitor/create performance test suites that run within performance testing environment, and work closely with developer teams to identify issues and key areas for improvement and optimizationProvide production support to the Operations and Application Support teams, work with Release Engineers to ensure smooth delivery of our applications to our clients
• Troubleshoot performance-related issues, identifying underlying problematic components, and communicating with other development teams to resolve
• Significant Java programming experience
• Experience with the Selenium, WebDriver, TestFX, TestComplete test frameworks

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

In the previous role, I was responsible for recommendations regarding the Quality Continuous Improvement (QCI) program to ensure it remains customer focused, consistent, effective and efficient.

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

• Strong experience in regulatory environment
• Second language desirable (French/German)
• Experience in planning and executing pharmaceutical supplier audits to identify, manage, correct and reduce significant risks / non-compliances
• Knowledge of technologies used in material supply base
• Knowledge of cGMP regulatory requirements and standards
• Masters in Biomedical & Biological Sciences, Chemistry, Biochemistry, or Pharmacy
• Experience with third party management
• Proficient in Italian, French, or German

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

In the previous role, I was responsible for quality input to product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs.

Please consider my experience and qualifications for this position:

• Recognized as expert by clients and colleagues
• Independent problem detection and implementation of problem solution
• Independent representation of department
• Knowledge of process improvement concepts and applications in R&D environment
• Respectful interactions with individuals with diverse views or backgrounds
• Knowledge and competency pertaining to DA, EMEA, NRC, DEA USDA to BIVI Standard Operating Procedures (SOPs), BIVI policies, regulatory guidelines and policies, regulatory guidelines and good scientific and documentation practices
• BSc Engineering or Biological Science
• Experience in a technical/engineering regulated environment – Medical Instrumentation preferable, but also consider automotive or aerospace