Associate, Assurance Cover Letter

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

Previously, I was responsible for high quality, professional day-to-day execution of internal audit engagements and projects in line with firm risk management practices.

Please consider my qualifications and experience:

• Willingness to take initiative and intelligent risks
• Strong knowledge of the principles of Operational Risk Management and Compliance disciplines
• Knowledge and understanding of related products and policies
• Expertise in leveraging existing operational procedures to make critical decisions that is sometimes subjective in nature
• Experience with QA/QC of Legal Entity data
• BS/BA in math, science, engineering or related technical field
• Working knowledge of 21 CFR Part 820, ISO 13485, ISO 9001 and familiarity with ISO 14971
• Analytical expertise and strong detail-orientation

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

Previously, I was responsible for high quality, professional day-to-day execution of internal audit engagements and projects in line with firm risk management practices for a large healthcare client.

Please consider my qualifications and experience:

• Track and trend on a monthly basis quality system data and indicators, including but not limited to Exceptions, Errors and Complaints
• Manages the audit process for the facility, organisation of the management team and staff to ensure a successful audit
• Drive, Right attitude and professionalism within previous roles
• Performs in-process review of documentation and ensures all product has been manufactured in compliance with cGMPs (Good manufacturing Practices) and SOPs (Standard Operating Procedures)
• Performs line clearance verifications of equipment and processing areas during changeovers between varying product types
• Issues, reviews and files various logs from areas of operation – including equipment logs, temperature and humidity monitoring
• Excellent organizational and planning skills with attention to detail paramount so that workflow is managed efficiently and able to work independently of direct supervision
• Experience with providing direct oversight and support to commercial manufacturing operations is highly preferred

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

Previously, I was responsible for leadership in areas of willingness & sustainability, Supplier Quality, Quality Risk Management, and Laboratory Compliance initiatives Key Performance Indicators.

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

• Manage changes and acts as a champion of change across the company
• Build a wide network and alliance, and utilizes stakeholder input to develop strategic thinking, distribute information and find opportunities for collaboration with external health professionals and Marketing colleagues
• Hold oneself accountable for performance and encourage others to achieve and be accountable for performance
• Quality Center (QC) - Intermediate
• Microsoft Office (Word, Excel, PowerPoint, Outlook, and Internet Explorer) - Intermediate
• Defect Tracking Tool (Team Foundation Server) - Intermediate
• Configuration Management System (Team Foundation Server) - Intermediate
• Able to work within a dynamic environment and work well with small interactive teams with ever changing requirements

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

In my previous role, I was responsible for high quality, professional day-to-day execution of internal audit engagements and projects in line with firm risk management practices to healthcare clients.

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

• Proficiency with Microsoft Word, Excel, PowerPoint, Visio, Adobe Acrobat
• Excellent time management, communicational and organisational skills
• Good skills in technical writing
• Experience in a virtual Quality role in a GMP environment for small molecule drug substance and dosage forms preferred
• Self-starter able to manage multiple competing demands
• Experience working in a project or program team preferred
• Knowledge of industry regulations to include 21 CFR 11, ISO 13485, ISO 9001, and Good Documentation Practice (GDP)
• Phones experience (Member Support, Payments Group, Customer Development)

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

In the previous role, I was responsible for high quality, professional day-to-day execution of internal audit engagements and projects within our BCM client vertical in line with firm risk management practices.

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

• File new labeling exhibits, specification sheets, expiration authorizations, and completed production documentation in appropriate files
• Coordinate testing/release of work-in-process with production, Quality Assurance and Planning departments
• Prepare and maintain essential databases, such as metal reject reports, Quality Assurance product labels and product release data
• Experience with reviewing manufacturing batch records, packaging records
• General understanding of Q7 (current) Good Manufacturing Practices
• Capacity for independent work
• Basic understanding of manufacturing terminology & processes
• Knowledge of inspection tools & processes