Compliance Quality Assurance Cover Letter

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

Previously, I was responsible for backup support for a wide variety of activities to ensure compliance with quality systems, procedures, policies to facilitate compliance with regulatory, customer and MA holder requirements.

Please consider my qualifications and experience:

• BS or BA in related field (Food Science, Biology, Chemistry)
• Certification and/or License -- Certified HACCP Manager
• AS9100/ISO Audit experience
• Experience influencing stakeholders in a matrixed environment
• GLP and GCP training and experience preferred
• Experience with CLIA, CAP or ISO certifications and accreditations preferred
• Experience conducting and hosting GCP audits/inspections preferred
• NFIP Underwriting, Claims, Customer Service

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

In my previous role, I was responsible for input, when strategically appropriate, to Regulatory authorities on key policies that impact computerized systems across the cGxPs.

Please consider my qualifications and experience:

• Thorough knowledge and practical application of Quality System Regulations 21 CFR 820, ISO 13485, ISO 14971, and IVDD
• Experience with ISO, FDA and other regulatory agency audits
• Experience in a multi-site, Business Unit environment, preferred
• Experience in compliance management within a rapid-growth, dynamic organization, preferred
• Strong working knowledge of and proven results in risk assessment, testing methodology, and internal control trends and best practices, as they relate to the financial services industry
• Clinical licensure and/or Certified Professional Compliance Officer, Certified Professional Coder or other applicable licensure/certifications preferred
• Strong demonstrated knowledge in development and implementation of policies and procedures for operation of the organization’s clinical compliance program
• Highly proficient utilizing Microsoft Office Suite

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

Previously, I was responsible for site leadership for quality operations, to implement clear policies, processes, and metrics in line with business strategy and regulatory requirements that drive consistency and compliance with quality 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:

• Requires GCP experience
• Quality auditor certification from a qualified international organization
• Proficient in two or more types of clinical audits (e.g., Investigator Sites, Internal Process, Vendors, Pharmacovigilance, Computer Systems Validation/21 CFR Part 11)
• Audit or related QA experience
• Excellent investigative/analytical/problem resolution skills
• Investigative experience with specific emphasis on AML/BSA/fraud prevention
• Demonstrated knowledge of USA PATRIOT Act/Bank Secrecy Act (BSA)/Anti-Money Laundering (AML) regulatory requirements
• Experience in the completion of Suspicious Activity Reports (SARs)

I submit this application to express my sincere interest in the compliance quality assurance position.

Previously, I was responsible for guidance for new programs and changes that impact important risk controls, policies, procedures, systems processes and training.

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:

• Strong knowledge in government regulations in order to ensure compliance of external and internal QA requirements
• Detail oriented and organized to ensure compliance in all areas of QA
• Related experience in QA in the pharmaceutical and animal health vaccine industry
• Knowledge of GMP/quality regulations and compliance regulations with practical experience in QC/QA in the pharmaceutical and animal health vaccine industry
• Utilizes QMS and other available data/metrics to assess effectiveness of site processes, establish site quality objectives/plans, and influence data-driven, risk-based decisions
• Advises corporate personnel regarding the development and implementation of quality strategy, identification of potential areas of concern, and impact of new business, government and regulatory developments on the site QMS
• Coordinates with other departments, corporate or marketing partners, and international offices to achieve project goals, including assigned corporate quality goals
• Promote organization’s growth and adherence to industry standards regarding product assurance, validations, design controls, document and data controls, supplier management, statistical techniques, This includes technical review and approval of individual scientific and engineering protocols and reports the identification of next-generation Quality System methods and toolsets

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

In the previous role, I was responsible for oversight and assurance that the Service Partners are operating in compliance with the AIB standards and policies on Risk, Audit, Access Management and Compliance.

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

• Maintain a broad knowledge of drug-development regulatory requirements and proficiency in ICH guidelines and FDA/international regulations relating to clinical development
• Strong leadership skills, including effective facilitation and communication abilities
• Experience with clinical trial logistics, including auditing clinical trials and assessing capabilities of potential clinical and non-clinical development programs from a quality and compliance perspective
• Drive implementation of company initiatives in terms of quality assurance and compliance with emerging domestic and international guidelines and regulations
• Knowledge of non-clinical development process is preferred
• Computer Information Systems Auditor (CISA)
• Previous experience with QAC
• Familiarity in Good Clinical Practices (GCPs) and/or Good Laboratory Practices (GLPs)