Quality Systems Cover Letter

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

In my previous role, I was responsible for recommendations to consolidate, standardize, simplify, and establish systems that are compliant with ISO, FDA (QSR), AATB, Corporate, and customer requirements.

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:

• Trained Auditor ideally lead auditor training and/or experience
• Knowledge of Quality Assurance Industry Standards in pharmaceuticals preferred
• Interface with personnel from other departments
• Exemplary organizational, communication and interpersonal skills a necessity
• Knowledge in various standards for management systems
• Support customer information requests from E-Tools
• Help create and update templates and forms for customer distribution based on Company guidelines
• Minimum 3yrs experience managing ISO Quality Management Systems and documentation

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

Previously, I was responsible for leadership and direction in quality systems and continuous improvement initiatives for commercial drug product and serves as a quality expert in GMP standards, policies, guidelines and procedures.

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

• Strong working knowledge of CLIA, CAP, FDA, ISO, and other requirements applicable to clinical laboratories
• Provide oversight to establish compliant Quality Management System (QMS) (includes but not limited to programs, guidelines and procedures related to all areas of the QMS such as Management Review, CAPA, Non-conformances, Quality Systems Review, Quality Planning, Quality Objectives, Analytics and Quality Scorecard, Change Control, Data and Document Management, Compute System Validations, Records Management and Training Management
• Partner across the company to drive standardization of Quality Systems
• Facilitate data input into the Management Review process that assures linkage of all ISI sites and provides reviews and visibility to Senior Management
• Hands on experience with formal quality management systems
• Hand on validation
• Proficient computer skills (ERP Database, MS Office Excel, Word, PowerPoint, OnBase)
• Office Management Package Windows

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

Previously, I was responsible for a focal point for GMP/ISO/GCP/21CFR Part 11 expertise in the Quality Systems group for consultation.

Please consider my qualifications and experience:

• ASQ Certified Quality Engineer, Quality Manager, Six Sigma, or Auditor preferred
• Experience/Qualification in Root Cause Analysis
• Ensuring efficient and effective document control process throughout Troup County operations
• Experience and knowledge of the Quality and Environmental Management Systems
• ISO based environment, with some internal auditing experience preferred
• Proven Computer skills, especially in spreadsheets and word processing
• Document Control Management Systems skills preferred
• Understanding of ISO Quest with some experience of the database preferred

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

In my previous role, I was responsible for quality Assurance support during FDA, corporate and notified body inspections/assessments during Quality Systems reviews.

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:

• Train, Facilitate Training, and Support Internal Auditors
• Facilitate and assist with company wide training, external audits and customer audits
• Have worked within a Quality function, ideally within a Consumer Healthcare, Pharmaceutical or FMCG similar environment
• Experience in the application and improvement of Quality Systems Corrective & Preventative Action, Document Control, Customer Complaints
• Familiarity with Control Document Management System (CDMS)
• Knowledge of TrackWise QMS software
• Working knowledge of FDA 21CFR 820, 803
• Knowledgeable in FDA and international regulations relevant to each project, , GMP, IDE, PMA, 510(k), and ISO

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

In the previous role, I was responsible for administrative support to Quality & Regulatory Mgr by serving as laboratory's liaison in dealing with FDA regulatory and accreditation activities.

Please consider my qualifications and experience:

• Supports the creation of a global, standard, enterprise-wide Quality Management System (QMS) and its integration into the respective SBU
• Incorporates standard work processes and activities across all SBU regions as part of the QMS
• Participates in QMS vetting by key stakeholders
• Develops and implements a plant internal cross-audit planning and facilitates execution
• Monitors external ISO- certification planning and supports audits by 3rd party certification bodies
• Reviews updates on ISO requirements and ensures compliance within the SBU and plants
• Tracks internal and external audit non-conformities and drives on-time issue resolution plans
• Reviews external audit conditions for the SBU and negotiates productivity improvements with 3rd party certification bodies together with Procurement