Senior Specialist, Quality Assurance Cover Letter

I submit this application to express my sincere interest in the senior specialist, quality assurance position.

In the previous role, I was responsible for cGMP phase appropriate QA oversight and application for Deviations/Investigations, CAPAs, Batch Record Reviews, Product Release and Change Control initiations as well as assist in any investigations in response to deviation, complaints, OOS and/or OOT.

Please consider my experience and qualifications for this position:

• BRC, SQF, FDA, and/or USDA audit experience is preferred
• Audit related certifications
• Fit an Agile team, and will be involved in the entire project from initiation to completion
• Who can communicate and are flexible, and who have Agile experience, Automation tools, and perhaps financial tools, such as ALM, JIRA and DevOps
• Who can think and challenge and are not afraid of raising their hand when something doesn’t make sense
• Who question “How can I make this problem disappear?” rather than say, “I can’t make the problem disappear”
• Who are interested in working in a ‘fin-tech’-like environment and are ready for fast-paced, leading edge development and quality assurance practices
• Cellular & Gene Therapy Products or Blood and Blood Product experience preferred

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

In my previous role, I was responsible for quality Assurance input to functional groups to evaluate and ensure proper closure of deviations, investigations, complaints, change controls and Corrective and Preventive Action Plans (CAPAs).

Please consider my experience and qualifications for this position:

• Author complaint investigations for high risk customer complaints
• Author, review, and approve procedures and other control documents associated with customer complaints
• Knowledge of commonly used concepts, practices, and procedures within QA field, GLP
• Thorough understanding of Good Laboratory Practices and/or other regulatory guidelines applicable to EPA/FDA/OECD regulations
• Knowledge of relevant laws, legal codes, government regulations and agency rules
• Experience with an electronic QMS tool, MasterControl preferred
• Sense of urgency and commitment to providing the best support possible to both internal and external clients
• Ensure regulations pertaining to Quality and Compliance for importation, distribution and wholesaling of the products on the markets

I submit this application to express my sincere interest in the senior specialist, quality assurance position.

Previously, I was responsible for operational leadership and expertise in the development, implementation, and training of cGMP compliant quality systems, such as document control, change control, investigations, deviations, CAPA, and product/customer complaints for fulfillment of QC testing.

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:

• Working knowledge of all standard Windows and Microsoft Office Software
• Proactive, result oriented, and strong attention for detail
• Experience or knowledge with packaging, chemical manufacturing processes and injection molding an asset
• Manage all aspects of the Corrective and Preventive Action (CAPA) program
• Perform other duties as directed by the Quality Systems Manager
• BS/BA in a technical field or comparable experience
• Clear understanding of Regulatory reporting and complaint file requirements for Medical Devices
• Clear understanding of requirements for Corrective and Preventive Action programs within a regulated industry

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

In the previous role, I was responsible for quality oversight for root cause analysis and product impact assessment for investigations as a result of deviations, OOS and OOT investigations.

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

• Have relevant experience with emphasis on functional and technical leadership
• Have experience in IT Project delivery with focus on operation / governance
• Strong stakeholder management and engagement skills with demonstrated success in Change Management
• Manage relationship with internal IT, business clients, and all stakeholders
• Experience in working with third-party vendors and development partners in a global environment
• Review of audit or inspection reports, responding to findings, and taking appropriate actions to ensure GMP compliance
• Manufacturing, Shop-floor, Laboratory, Supply Chain Management or related experience
• Work in dynamic environment and global teams

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

In my previous role, I was responsible for strategy for Quality Systems to include Document Control, Training, Internal Audits, Compliance, Complaint investigations, CAPA and continuous improvements.

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:

• Knowledge of quality related pharmaceutical regulations
• Experience working in a Pharmaceutical/Biotechnology industry
• High level of expertise and exposure with agency regulations, such as 21 CFR Part 11, Part 58, Part 210, Part 211 from the US Food and Drug Administration
• High level of expertise in SLC methodology (e.g., V-model, waterfall, agile, spiral) including change management
• Extensive experience providing oversight for adherence to enterprise SLC and procedures
• Proficient skills dealing with and understanding typical laboratory facilities and equipment
• Excellent written and communication skills including thorough knowledge of Good Documentation Practices
• Experience with calibration and qualification