Associate Quality Assurance Associate Cover Letter

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

Previously, I was responsible for expert advice to the area on Good Manufacturing Practice/Good Development Practice/Good Distribution Practice / Good Laboratory Practice within the site, with reference to Good Manufacturing Practice guidelines and regulations.

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

• Presentation/influencing skills
• Knowledge and demonstrated success in training and implementation
• Demonstrate skills in delivering complex information
• Bigger pictures/ strategic perspective
• Sustain performance
• Consider stakeholders, including Marketing colleagues, health professional, patients, in developing strategies and future directions
• Develop organizational vision within the global context and understanding of the business needs and information needs
• Utilize and encourage innovative approaches to build and maintain a competitive advantage

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

In the previous role, I was responsible for assistance to the Executive Director Global R&D QA or designee in FDA, EPA and Corporate inspections of Animal Health (AH) facilities.

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

• Review of support documentation
• Site Internal Audits
• Should be able to work with minimal support
• Strong knowledge of, or experience with, quality system improvement and maintenance
• Strong internal or external auditor experience
• Experience interacting with customers to resolve quality issues
• Experience managing calibration systems
• Hands-on experience with gage R&R/MSA

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

In my previous role, I was responsible for gLP regulatory perspective or quality advice and guidance to the stakeholder areas and within QA.

Please consider my experience and qualifications for this position:

• Work with the Business Analyst, AD & Users teams to ensure that requirements documentation can be easily translated into functional test plans, and that testing plans have been completed
• Working experience with online advertising
• Experience following brand guidelines
• Demonstrated understanding of or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA 21 CFR 820 and ISO 13485
• Demonstrated understanding of or aptitude to understand product development lifecycles, design change and document change control, process verification and validation methodologies, production process control methodologies in a medical device environment
• Excellent verbal communication and writing skills in the context of reports, business correspondence, procedures
• Strong computer skills and experience with Windows operating system and Microsoft Office
• Previous process migration experience is highly desirable

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

Previously, I was responsible for day-to-day leadership to QA&FS Departments and act as the primary liaison to outside laboratories, and to external regulatory agencies (FDA, USDA).

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

• Experience with facility and utility commissioning
• Experience with bioreactors, parenteral filling lines, freeze dryers
• Experience executing Cleaning Validation, Process Validation, Computer System Validation
• Performs in-process document auditing and product quality checks in production and ensures all issues are communicated to production employees, production management and Quality Assurance (QA) management
• Performs Final Release auditing of batch documentation ensure all product has been manufactured in compliance with cGMP's (Good Manufacturing Practices) and SOP's (Standard Operating Procedures)
• Performs compliance audits in all production departments and prepares result reports for product and QA management
• Coaching and training operators and supervisors on cGMP practices
• Performs sampling for the Environmental Microbial Monitoring program

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

In the previous role, I was responsible for one on one training to others in the organizations on commonly used quality related systems, i.e.

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:

• Experience with Regulus and/or Trackwise preferred
• Perform substantive testing/evaluation of balances & other information (based on transaction nature and underlying client/contractual information) in support of Quality Assurance agenda
• Chartered Accountant and / or an MBA in Finance is desirable
• Internal auditor trained / experienced
• Scientific background either via experience or qualification
• Develop, implement and maintain the local quality management system and ensure alignment with current and new Global Quality initiatives
• Where appropriate, develop and implement additional standard operating procedures or work instructions to fulfil local Regulatory/Quality requirements or business needs
• Identify and manage continuous improvement activities through the local change management system from initiation through to effectiveness