Quality Compliance Specialist Cover Letter

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

In my previous role, I was responsible for technical and strategic leadership and subject matter expertise regarding ISO 9001, ISO 27001, GDPR, HIPAA, and 21 CFR Part 11 GMP Documentation and Regulations.

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

• Excellent interpersonal and communication skills, problem solving skills, and networking/relationship-building capabilities
• Conduct business with a sense of urgency and work in a dynamic environment manage to short deadlines
• Strong team player, demonstrating a high level of cooperation and collaboration
• Learning Management System (LMS), ISO 9001, ISO 13485, cGMP, Train the Trainer
• Able to prioritize and complete multiple tasks
• Strong LMS skills
• Can comfortably and effectively confront difficult situations and issues in a timely and appropriate manner
• Experienced in working effectively on cross-functional teams

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

In the previous role, I was responsible for quality oversight to design and implementation of computerized systems to regulated activities to ensure compliance to applicable regulations (e.g., 21 CFR Part 11, GxP).

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:

• PMI and/or Six Sigma Certification would be highly desirable but not essential
• Familiar with relevant regulations and standards (CFDA, 21 CFR 820, MDR, ISO13485, ISO14971), lead auditor on ISO13485 is preferred
• Familiar with product lifecycle management processes
• Experiences as an auditor, quality engineer, compliance analyst, quality assurance specialist, or compliance specialist with a major pharmaceutical organization
• Experience managing external quality failures, 483s and Warning Letters, and/or managing a product recall
• Certified Quality Auditor or Engineer (CQA, CQE) nice to have
• Strong knowledge of ISO, FDA, EMA and ICH requirements
• Quality Auditor, Six Sigma, or equivalent certification/education preferred

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

In the previous role, I was responsible for continuing education and consultation throughout organization on 21 CFR Part 11 and other regulatory requirements as needed.

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

• Pharmaceutical Quality Assurance Experience Preferred
• Prior experience managing regulatory compliance programs and responsibilities
• Familiarity with GMP quality systems, particularly in food, nutrition or dietary supplements
• Prior experience using Part 11 compliance quality management software
• Familiarity with regulatory reporting requirements for medical devices
• Direct complaint handling experience, including adverse event reporting is preferred
• Experience with FDA, HACCP, Food Safety, SQF, GFSI, BRC is preferred
• Good computer skills (QMS, Microsoft Word, Excel, and PowerPoint)

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

In the previous role, I was responsible for leadership to establish life cycle requirements for the Computerized and IT Systems that are consistent with Corporate Directives and regulations (e.g 21 CFR Part 11) to ensure compliance and alignment with business and regulatory objectives;.

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

• Possess good interpersonal and interview skills, a strong attention to detail, coupled with an uncompromising dedication to ethical, professional behavior
• Possess proven negotiation and conflict resolution skills
• Working knowledge of FDA Regulations, local country regulations, application of Good Laboratory Practices, and application of Good Manufacturing Practices
• Able to present areas of responsibility to regulatory agencies during inspections
• Advanced knowledge of quality systems (ETQ, GSS, ) and investigation tools is preferred
• Experience with plant manufacturing processes is preferred
• Act as Case Lead for the Significant Quality Events (SQEs) in PSBU, help with root-cause analysis and creation of Corrective and Preventative Action Plans (CAPAs), conduct CAPA verifications and CAPA effectiveness checks
• Supports study teams in preparations and follow-up on site audits, conduct CAPA reviews and CAPA verifications

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

In my previous role, I was responsible for guidance to site managers and employees to ensure compliance with Teva's global standards, regulatory guidelines and cGMP requirements.

Please consider my qualifications and experience:

• Basic or advanced word processing skills
• Basic or advanced spreadsheet skills
• Basic or advanced typing skills
• Experience with production system leadership and tools (KPI tracking, Six sigma, Lean)
• Assist management in the tracking and monitoring of the Complaint/Adverse Event and Deviation/CAPA Management Systems
• Assist in the reporting and assessment of critical data by indexing, archival, and retrieval of Complaint/Adverse Event and Deviation/CAPA System data
• Participates in Lean Six Sigma process improvement projects
• Perform SOP development and review