Compliance / Quality Specialist Cover Letter

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

Previously, I was responsible for specific training to new pharmacy staff within 30 days of hire in areas of third party, NY Medicaid, Medicare, regulatory compliance and controlled substances.

Please consider my experience and qualifications for this position:

• HACCP Food Safety and Quality Management
• PMO/Grade A Knowledge
• LACF Regulatory Knowledge
• State and Federal Regulatory
• Knowledge of kosher and organic processes and regulations for food manufacturing
• Present/discuss GMP deliverables as the SME with Domestic and
• International Regulatory Agency inspectors and auditors
• Strong knowledge and experience in the implementation of operational excellence management systems

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

Previously, I was responsible for qMS technical support during third-party (registrar) and customer assessments at the corporate office, and provide assistance for branch locations as requested.

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:

• Assist the relevant operational staff (Clinical Trial Managers, Project Managers and Project Directors) in the development and implementation of clinical quality plans at the department and study level
• Assist project/portfolio teams with assessment of quality metrics, SQE trends, Protocol Deviations, Site Health issues, Clinical Quality Risk Management plans and/ or key quality/performance indicators
• Identify, escalate and mitigate potential quality issues, GCP violations and non-compliance with internal or client SOPs/processes on project/portfolio/department level
• Review of deliverables on project/portfolio/department level in conjunction with issues that are affecting the quality of the clinical deliverables to ensure quality standards are achieved
• Scheduling and managing internal and external meetings, producing presentation/s training materials and generating meeting minutes
• Preparation and distribution of regular status reports (e.g., trends in Clinical QC findings) both internally and externally
• Occasional travel domestic and/or international
• Have significant CAPA experience (management of SQEs/audits)

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

In my previous role, I was responsible for oversight of third party providers, focusing on compliance with meeting agreed to service and compliance levels.

Please consider my experience and qualifications for this position:

• Familiarity with HACCP based risk assessment procedures or similar methodology
• Knowledge of Import/Export experience preferred
• Experience with interpretation of international export and import regulations preferred
• Knowledge of FDA regulations and ISO standards applicable to the medical device industry preferred
• Knowledge and experience with FAA regulatory guidance
• Knowledge in SMS and associated process
• Willingness to assist managers, staff, and government agencies with the highest level of professionalism
• Self-motivated and able to work with minimal supervision in support of the Flight Safety department and the D.O

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

Previously, I was responsible for strategic advice and counsel to support the development and monitoring of Anti-Money Laundering training, risk and assessment programs.

Please consider my experience and qualifications for this position:

• Team player and lead by example
• Acts as a lead specialist to provide project-, program-, and / or initiative-related direction and guidance for other specialists within the department and/or collaboratively with other departments
• Writes narrative reports to interpret regulatory specifications, explain programs and results of programs, and document findings and limitations of department interventions
• Leads quality improvement activities, meetings and discussions with and between other departments within the organization
• Evaluates project/program activities and results to identify opportunities for improvement
• Other tasks, duties, projects and programs as assigned
• Experience performing Good Manufacturing Practices (GMP) audits of laboratories that perform testing for API, DS and DP
• Advanced knowledge of U.S. and European regulations, compendia, guidance and industry practice as they pertain to the testing of biological products

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

Previously, I was responsible for regulatory support including: ingredient disclosure & compliance, Safety Data Sheets, WERCSmart, DOT hazardous materials shipping, US Customs & partner government agencies, and the management of DEA controlled substances.

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:

• Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards
• Expert Knowledge and application of GMP principles
• Experience working in quality assurance
• Knowledge of GMP's and industry regulations
• Computer literate, with intermediate skill in the use of Word, Excel and Outlook, and some knowledge of relational database systems, Agile Project Management system
• Flexibility to work across the UK sites, with some global travel
• Be able to work effectively and efficiently in a team environment
• Functional knowledge of global cGMP regulations and quality systems requirements for pharmaceutical or biopharmaceutical operations