Assurance Associate Cover Letter

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

Previously, I was responsible for written documentation of audit results to the Supervisors, Managers and Production Accounting on a weekly basis.

Please consider my experience and qualifications for this position:

• Basic knowledge of the functions and workflow in Cleanup
• Effective knowledge of service and transaction types system processing logic
• Basic knowledge of the P&C Products
• Effective knowledge of Excel
• Strong working knowledge of cGMP regulations (for , 21CFR4, 21CFR211, 21CFR820, ISO13485), and ICH guidance’s
• Develops plans, documents and/or processes for conducting GCP audits, including for-cause audits, providing support for and independent oversight of the GCP infrastructure and assigned clinical studies, writes audit reports and communicates findings and/or issues to the appropriate manager(s)
• Conducts function specific audits
• Works in conjunction with contract auditors to conduct audits, finalizes reporting, and ensures follow-up

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

In my previous role, I was responsible for support to new clients as well as internal sales staff across our professional software accounting portfolio.

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

• Experience performing deviation investigations including CAPA planning and management is highly preferred
• MS Office applications, LIMS, Trackwise, and Oracle are preferred
• Experience with, or direct knowledge of quality system elements
• Strong attention to detail, reviewing batch record and documentation for adherence to SOP format requirements
• Work experience from pharmaceutical industry, in QA preferably
• Willingness to travel for visits to client head offices and operational sites, sometimes at short notice (concentrated January – May)
• Review production records
• Issue/Reconcile QC laboratory documentation for execution according to SOPs

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

In my previous role, I was responsible for support during GMP audits to the audit management team and work to resolve audit observations as required.

Please consider my experience and qualifications for this position:

• HP Loadrunner - Intermediate
• HTML - Beginner
• Javascript - Beginner
• Selenium - Beginner
• Exposure to audits (performing, conducting, participating)
• Quality Systems exposure (Document Control, Change Control, NCRs, CAPA)
• Thorough working knowledge of QMS documentation requirements
• Knowledge of ISO 13485, and cGMP, and regulations

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

Previously, I was responsible for expert knowledge and promote awareness of audit practices and effective controls to others throughout the organization.

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

• Demonstrable working knowledge of QA processes, disciplines and standards
• Working knowledge of QC/ALM for test planning, execution and tracking
• Monitor and evaluate calls conducted by Sales, Service and Operations
• Provide timely, consistent and calibrated feedback to employees & managers
• Develop, distribute, archive and maintain regular recurring and ad-hoc reporting
• Collaborate with the Training team to further enhance employee development and feedback
• Maintain professional and technical knowledge by attending training sessions, reviewing materials and following best practices across the industry
• Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct

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

In my previous role, I was responsible for expertise from a technical perspective on internal / external GMP audits of facilities and systems and works to resolve audit observations as required.

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:

• High School Diploma or equivalent education, some college preferred
• Experience in a virtual Quality role in a GMP environment for small molecule drug substances and dosage forms (oral and parenteral) preferred
• Hands-on experience with CI tools such as Jenkins / Bamboo
• Have advanced-level knowledge of Excel
• Quality Conscience
• Conduct batch record and test data reviews, and approve batches for release
• Assist in maintaining compliance of Environmental Monitoring, Equipment Calibration, and the Equipment Maintenance Program
• Issue Deviation, CAPA, and OOS investigations