Quality / Compliance Cover Letter

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

In the previous role, I was responsible for ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current cGMP, Good Documentation Practices (GDP) and other applicable regulations.

Please consider my experience and qualifications for this position:

• Experience with Cubi Scan or similar system
• Proficiency with Red Prairie or other WMS, Bartender, QCloud, and/or QT9
• Experience in MS Office (Word, Excel, Outlook, PowerPoint)
• Knowledge of Quality systems and applicable regulations/standards including ISO 13485, 21 CFR 820 and 21 CFR 1271
• Corrective and Preventative Action (CAPA) experience (internal audits)
• Microsoft Office, TrackWise
• Bachelor of Science in MT (ASCP)
• AABB certification preferred

I submit this application to express my sincere interest in the quality / compliance position.

In the previous role, I was responsible for support in the creation of the Sourcing “Golden Package” as it relates to internal and external compliance regulations.

Please consider my qualifications and experience:

• Strong data architecture skill set including a deep understanding of database concepts and data logic
• Working knowledge of SQL and SQL Developer tools
• Prior demonstrated Finance Business Analyst and/or hands on Project Management experience
• Demonstrated experience in developing detailed written policies and procedures
• Experience in gathering and analyzing health data and drawing conclusions
• Experience in applying scalable, disciplined and coordinated operational and technological approaches to improve health care quality and member experience and reduce costs of care
• Continuous quality improvement/business process improvement
• Excellent demonstration of flexibility and change leadership

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

In my previous role, I was responsible for regulatory inspection support to MSD Sites as it relates to the Global cGMP & Compliance Auditing program, status of audits, and specific audit results.

Please consider my experience and qualifications for this position:

• Problem solving and statistical skills using quality tools (Pareto analysis, statistical process control, multi-variant DOE )
• Apply effective time management, critical thinking, problem solving and collaborative approaches to improving training program
• Willingness to travel to various meetings or sites, including overnight trips
• Subsidized onsite parking and public transportation passes
• ASQ desirable
• In depth knowledge of the regulatory environment for the manufacture of drugs, and biologicals products
• Strong leadership skills and demonstrated success in managing a team, both internal and external resources
• PMP Certificated is preferred

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

In the previous role, I was responsible for guidance and support on matters of FDA / ISO regulations to cross-functional departments and staff.

Please consider my experience and qualifications for this position:

• Handle day-to-day communication with Market Managers & Global Supply Operations regarding tax rate changes, updates, and disputes
• Develop process around content management practices
• Perform the upload of rates, including the identification and loading of custom data
• Develop a solid understanding of company data logging and data architecture in order to be able to assess the impact of potential changes to tax & fee decisions
• Perform data analytics to assist in the audit of pricing matters
• Assist in company projects and initiatives including defining requirements, developing test plans, and conducting UAT
• Work with internal partners, business sponsors, product managers, developers, and other teams to develop and review project designs and business requirements
• Research tax rates, fees, and rules and assist in supporting tax & fee through technological solutions

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

In the previous role, I was responsible for regulatory and Compliance Support as it relates to DEA and medical areas within a clinic.

Please consider my experience and qualifications for this position:

• Broad understanding of Consumer centric quality management principles, design of new Processes and Standards management and Supply chain models, Quality Performance & Compliance Reporting, Continual Improvement, Product and Materials Test & Release, Product Chemical Lab Testing & Review processes
• Working knowledge of SPC, ISO 9000, Six Sigma and CI tools (eg UPS, RCA, CAPA)
• Excellent interpersonal communication skills, a positive attitude, a good sense of humor/fun and empathy
• Independently and directly represent TPUSA Quality to make decisions on complaint program design with business/marketing partners, affiliates, Global Pharmacovigilance and Global Medical Affairs resulting from each business change, including acquisitions, product launches, new business partners and new customer bases to ensure continued compliance and clear business process
• Ensure alignment of PV and product complaint management systems through effective process and technology design and management, and effective collaboration with internal and external partners
• Establish strategic requirements for enhancement of IT systems/technology platforms for complaint information management and data analysis to enable timely risk identification and to assure regulatory compliance
• Develop and maintain a broad network of relationships within Takeda’s global environment
• Lead multidisciplinary, cross-functional and cross-business teams to create strategies for risk assessment and mitigation