Auditor Quality Assurance Cover Letter

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

In my previous role, I was responsible for constructive technical challenge to the design and development of a capital systems from a product/system and process perspective.

Please consider my experience and qualifications for this position:

• Conduct audits of Pharmaceutical Development Manufacturing Facility to ensure compliance with CGMP, DEA, Corporate and pharmaceutical development SOPs
• Good Computer skills, including in depth knowledge of Word and Excel
• Good understanding of compliance regulations and audit techniques
• Full understanding of FDA, CGMP, and DEA regulations pertaining to Pharmaceutical manufacturing
• Safety procedures associated with department
• MBA, CPA, CIA or CISA
• Knowledge of 14 CFR Part 121 maintenance requirements
• Knowledge of maintenance practices, CFR’s, ATA 103, NFPA 407

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

In the previous role, I was responsible for guidance to MFG, E T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified.

Please consider my experience and qualifications for this position:

• Health and Safety - level Two
• Food hygiene - level Two
• Allergen Awareness
• Basic disinfection principles
• Basic weight legislation
• Thorough knowledge of cGMP’s
• ISO Lead Auditor certification is mandatory
• Perform task requiring manual dexterity

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

Previously, I was responsible for leadership and guidance in the Quality Assurance organization to ensure the appropriate and compliant development and implementation of strategies regarding the cGMP processes.

Please consider my qualifications and experience:

• C.A.S.E Level III or IV authorization with 1A and/or 2A rating
• Knowledge of maintenance practices, CFR
• Complete IPC 610/J-STD-001 Training and pass post training assessment
• Complete hand solder training and pass post training assessment
• Knowledge of 21CFR Part 11, 21 CFR820.20, ISO 9001/13495
• Experience with CAPA Management and GMPs experience with medical devices are preferred
• Dental/Healthcare experiences, preferred
• Experience in a Quality Assurance or Business Audit function or role, preferred

I would like to submit my application for the auditor quality assurance opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for direction to product and project teams from a Systems Development Life Cycle process and compliance perspective.

Please consider my experience and qualifications for this position:

• Strong knowledge of Dutch and English
• Good communication and advisory skills
• ACDIS administered certification of CCDS OR
• AHIMA administered certification of CDIP
• Current Medical Coding certification through AAPC, American Health Information Management Association (AHIMA) and/or through an organization accredited by the National Commission for Certifying Agencies (NCAA) for Medical Coding (e.g., Certified Professional Coder (CPC), Certified Outpatient Coding (COC), Certified Inpatient Coder (CIC), Certified Coding Associate (CCA), Certified Coding Specialist (CCS), or Certified Coding Specialist-Physician-based (CCS-P))
• Ensure duties are carried out according to the principles of GLP and GMP
• Perform the review /approval of GxP documents, including protocols, technical specification (TS), batch records, workbooks, SOPs, validation protocols, and all other QMS documentation
• Perform data audit and approval of completed manufacturing or testing documentation as they comply with the stated regulatory standard and the approved TS, protocol or SOPs

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

In my previous role, I was responsible for insight, advice and ideas to help shape business changes and projects from a quality perspective from the outset.

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

• Navigate easily in Microsoft office, specifically Excel
• Document control for medical device or pharma setting
• Preferred experience with the internal claims systems and processes
• Understand and follow QA procedures while auditing all clients' mail kits
• Provide feedback to manager/supervisor of any excessive errors discovere
• Knowledge of Microsoft Office ® applications and spreadsheet programs such as Access and Excel
• Relevant experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including relevant experience of applicable GxP auditing
• Understanding of contemporary auditing terminology