Principal Specialist Cover Letter

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

In my previous role, I was responsible for independent QA input to process validation projects in support of commercial biomanufacturing in an aseptic or sterile manufacturing environment.

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:

• Industry recognized Certifications preferred CCDP, CCNA, CCNP
• Expertise in Cisco LAN/WAN/Voice/Video connectivity technology including IOS switches, routers, unified communication, video infrastructure, WAAS, wireless controller and AP
• Proficiency in routing and switching protocols, satellite communication / VSAT
• Experience with using network monitoring tools, such as Solarwinds, Netflow, Cisco Prime Infrastructure to troubleshoot application and network issues
• Requires a Quality Engineer / Auditor certification from ASQ or equivalent and qualification as a Lead Auditor
• Advanced/in-depth knowledge of relevant regulations and guidances understanding of scientific methods and processes used to manufacture, test, evaluate and distribute biological and pharmaceutical products
• In-depth knowledge of Quality Systems and related norms
• Knowledge of process improvement concepts and applications in compliance environment

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

Previously, I was responsible for quality oversight of projects including: Equipment Qualification, Method Validation, Aseptic process validation, Process Validation, Work Order Review, Cleaning and Sterilization Validation, Shipping Validation, Regulatory Submissions, and.

Please consider my experience and qualifications for this position:

• Provide support and guidance related to the corporation’s high-risk driver program, motor vehicle record review program, vehicle medical exception request and authorization program, emergency response programs, BBP and Tb programs, web-based training programs, commentary drive program, scorecard metrics reporting, safety incentive and recognition programs, and other communication initiatives as appropriate (newsletters, safety awareness campaigns)
• Establish project scope, cost and schedule
• Apply advanced technical knowledge/skills to EHS programs and systems
• Proven leadership at a national or state level related to English education and/or assessment
• Deep knowledge of the ELA Common Core State Standards and implications for instruction and assessment
• Strong computer skills including familiarity with Microsoft Office and Google collaborative products
• Preferred--documented research activities, including publication of white papers or publication of articles in education, trade, or other peer-reviewed journals or regional newsletters
• Experience providing professional development activities for educators and/or other professionals, such as interpretation of assessment results, development of assessments for a variety of purposes, and instructional or curricular relationships to assessment, strongly preferred

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

Previously, I was responsible for technical support to identify the causes for non-conformances and process failures and to implement corrections to assure process performance and compliance against Depuy Synthes QSR, GMP and ISO requirements for the manufacturing process.

Please consider my qualifications and experience:

• Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook)
• Competent user of SAP/Materials Management Module,MS Project or other Project Management software
• Knowledge of VMWare View/Horizon / VSphere / ThinAPP / Workstation
• Plateau or other Learning Management Systems
• Experience with one ormore e-learning software tools (eg Captivate, Articulate, Lectora, or Camtasia)
• Microsoft Project and Excel
• American Society for Quality (ASQ) Certified Auditor
• Experience training employees to conduct audits

I submit this application to express my sincere interest in the principal specialist position.

In my previous role, I was responsible for technical leadership and direction for the Manufacturing department, Subject Matter Expert (SME) in the formulation, aseptic filling process, isolator technology and representation at various regulatory audits.

Please consider my experience and qualifications for this position:

• Experience in the management of teams supporting subcontracts bid proposals and project subcontract administration within EPCI industries
• ADOT experience
• Understanding of health care system requirements (outcomes research, cost)
• Other requirements (certifications and so forth)
• Demonstrates full knowledge in assigned area and is an experienced sole contributor
• Works with management team to develop processes, best practices and procedures for the Compliance department
• Leverages subject matter expertise to provide guidance on operational issues, technical questions and business processes
• Anticipates future business needs and identifies opportunities to enhance operations and processes

I would like to submit my application for the principal specialist opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for technical leadership for manufacturing process changes, process validation, discrepancy and investigation evaluations, change control, and regulatory submissions.

Please consider my experience and qualifications for this position:

• Need experience with Enterprise Cloud Services solutions AWS, Google, Azure
• The gathering, analyzing and reporting of relevant regulatory data for internal and external audiences
• Green belt or suitable alternative
• MSD Certified Auditor
• Working knowledge of cGMP, pharmaceutical and personal care product regulatory frameworks, and biocide registration processes
• BS in Engineering, Computer Science or appropriate work expertise
• Proven track record of solving complex problems in an innovative manner by engaging and gaining trust of technical influencers and users
• Experience with interfacing with customers and explaining the value of the solutions and technology