Sr. Specialist, Audit Program

3 weeks ago


Scottsdale, United States West Pharmaceutical Services Full time

Job Summary

:

In this role, you will support the external (customer, regulatory, and corporate) and internal audit programs for a medical device manufacturing facility. Assists in establishing systems to support the audit programs at the facility and to drive continuous improvements and minimize audit observations. Maintains the internal and external audit schedule. Preps for and hosts audits. Creates the responses to audit reports. Ensures completion of auditing corrections. Performs all duties associated with compliance-related items for ISO standards and cGMPs. 

Essential Duties and Responsibilities: 

Maintain the internal and external audit schedule. Coordinate customer and regulatory audits as needed throughout the year. Ensure internal audits are performed on time. 

Ensures the site is prepared for each audit. Ensures requested documents are prepared and the facility is audit ready. 

Acts as audit host. Gives site visitor presentation. Conducts facility tour with auditor. Is Front Room lead during audit. Main point of contact with auditor prior to, during, and after the audit. 

Receives audit reports and is responsible for coordinating the audit responses. Works with management and technical staff in performing root cause analysis and implementing corrective and preventive actions to preclude recurrence. Ensures responses are sent by the due date required. 

Coordinates with observation owners to ensure corrections to audit observations are performed by the due date.

Hosts near-miss meetings with site SME’s post-audit to prevent future findings. 

Provide training to site employees on regulatory/ISO/GMP/GDP standard requirements, as needed. 

Maintains audit databases and ensures they are up to date.

Ensures audit KPIs are monitored and in compliance with internal requirements. Performs tracking and trending of audit metrics. 

Utilizes knowledge of International Standards and Federal Regulations (i.e. ISO 13485/21 CFR 820/EU MDR) to maintain the quality management system. 

May work with supplier onboarding process and PO generation, as needed. 

May execute internal audits following ISO 13485/21 CFR 820/EU MDR standards and internal procedures. 

Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules. 

Exhibits regular, reliable, punctual and predictable attendance. 

Other duties as assigned. 

Basic Qualifications:

Strong analytical thinking and complex problem-solving skills 

Bachelor’s degree in engineering or similar degree, or equivalent work experience. 

ISO 13485 Lead Auditor certified 

Experience working within FDA CFRs, ISO 13485, EU MDR or other regulated environments. 

Experience completing CAPAs and/or complex investigations. 

Preferred Knowledge, Skills and Abilities: 

EU MDR auditor certified 

CQA/ASQ certifed 

Able to interface with customers and meeting customer expectations 

Experience operating within the Medical Device regulations. 

Ability to work with interdisciplinary teams. 

Experience with Project Management tools and able to provide support and contribute in Lean Sigma programs and activities towards delivery of the set target

Willingness to learn manufacturing procedures and aid with improvements via Quality Management. 

Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description

Able to comply with the company’s safety policy at all times 

Able to comply with the company’s quality policy at all times 

Travel Requirements: 

None.

Physical and Mental Requirements: 

Need to have extreme attention to detail 

Ability to work in an office and/or manufacturing environment. May need to stand or sit for extended periods of time 

Medi



  • Scottsdale, Arizona, United States West Pharmaceutical Services Full time

    Job Summary:We are seeking a highly skilled Senior Audit Specialist to join our team at West Pharmaceutical Services. In this role, you will play a critical part in supporting the external and internal audit programs for our medical device manufacturing facility.Key Responsibilities:Maintain the internal and external audit schedule, ensuring timely...


  • Scottsdale, Arizona, United States West Pharmaceutical Services Full time

    Job Overview In this position, you will play a crucial role in supporting both external (customer, regulatory, and corporate) and internal audit initiatives for a medical device manufacturing organization. Your responsibilities will include establishing systems that enhance the audit programs at the facility, driving continuous improvements, and...


  • Scottsdale, Arizona, United States West Pharmaceutical Services Full time

    Job Overview In this position, you will play a crucial role in supporting both external (customer, regulatory, and corporate) and internal audit initiatives for a medical device manufacturing organization. You will assist in developing systems that bolster the audit programs at the facility, aiming to drive ongoing enhancements and reduce audit...


  • Scottsdale, Arizona, United States West Pharmaceutical Services Full time

    Job Overview In this position, you will play a crucial role in supporting both external (customer, regulatory, and corporate) and internal audit initiatives for a medical device manufacturing organization. You will assist in developing systems that bolster the audit programs at the facility, aiming to drive ongoing enhancements and reduce audit...


  • Scottsdale, Arizona, United States Cameron Craig Group Full time

    We are a dynamic CPA firm seeking to enhance our team with a Lead Audit Specialist.Key Responsibilities:Establish and nurture client relationships by collecting data, addressing concerns, and offering suggestions for operational enhancements.Oversee client audit, review, and compilation projects, including the planning, execution, direction, and completion...


  • Scottsdale, Arizona, United States Bridgeway Professionals Inc Full time

    Bridgeway Professionals Inc is a dynamic CPA firm seeking a Lead Audit Specialist to enhance our team.Key Responsibilities:Build and maintain strong client relationships while offering insightful recommendations for operational enhancements.Oversee audit projects from initial planning stages through to final execution.Exhibit a thorough understanding of...

  • Internal Audit

    2 weeks ago


    Scottsdale, United States Taylor Morrison Full time

    Job Description Summary As the Internal Audit & Field Rotation Program Senior at Taylor Morrison, you will participate in the company's internal control and risk management activities through audits and SOX and lead the development of a comprehensive Audit-to-Field Rotation Program. This program is designed to transition candidates into corporate and field...

  • Internal Audit

    3 weeks ago


    Scottsdale, United States Taylor Morrison Full time

    As the Internal Audit & Field Rotation Program Senior at Taylor Morrison, you will participate in the companys internal control and risk management activities through audits and SOX and lead the development of a comprehensive Audit-to-Field Rotation Field, Audit, Internal, Business Operations, Program, Accounting, Construction, Business Services


  • Scottsdale, Arizona, United States Jobot Full time

    Job Title: Permanent Audit SeniorAbout Us:Jobot is a distinguished auditing and consulting firm dedicated to serving governmental and nonprofit organizations. Our mission is to thoroughly understand our clients' unique operations, reporting goals, and compliance requirements to provide tailored services.Job Overview:We are on the lookout for a skilled and...

  • Sr. Problem Manager

    18 hours ago


    Scottsdale, United States IMPACT Technology Recruiting Full time

    Title: Sr. Problem ManagerLocation: Scottsdale, AZ Type of Position: Contract Description: Under minimal supervision, The ITSM Sr. Process Specialist – Proactive Problem Manager will manage all activities in the lifecycle of proactive problem management. The Problem Manager is responsible for working with Process Managers and stakeholders to identify...

  • Sr. Problem Manager

    10 hours ago


    Scottsdale, United States IMPACT Technology Recruiting Full time

    Title: Sr. Problem ManagerLocation: Scottsdale, AZ Type of Position: Contract Description: Under minimal supervision, The ITSM Sr. Process Specialist – Proactive Problem Manager will manage all activities in the lifecycle of proactive problem management. The Problem Manager is responsible for working with Process Managers and stakeholders to identify...


  • Scottsdale, United States HonorHealth Full time

    Overview Looking to be part of something more meaningful? At HonorHealth, you’ll be part of a team, creating a multi-dimensional care experience for our patients. You’ll have opportunities to make a difference. From our Ambassador Movement to our robust training and development programs, you can select where and how you want to make an...


  • Scottsdale, United States General Dynamics Mission Systems Full time

    Bachelor's degree in Accounting, Finance, Business or equivalent experience is required. An additional year of directly related experience is preferred. Due to the nature of work performed within our facilities, U.S. citizenship is required. Responsi Finance, Specialist, Program, Accounting, Program Analyst, Banking, Technology


  • Scottsdale, United States HonorHealth Full time

    Overview Looking to be part of something more meaningful? At HonorHealth, you'll be part of a team, creating a multi-dimensional care experience for our patients. You'll have opportunities to make a difference. From our Ambassador Movement to our robust training and development programs, you can select where and how you want to make an impact. HonorHealth...


  • Scottsdale, United States Firetrace International Full time

    Job DescriptionJob DescriptionFiretrace International is Looking for a Sr. Customer Support SpecialistDo you want to be a part of a forward-thinking team inside a global company? At Firetrace, our purpose is to protect lives and livelihoods by eliminating the impact of fire.Firstly, a bit about usFiretrace International, a subsidiary of Halma plc, is a...

  • Payroll Accountant

    6 days ago


    Scottsdale, United States Ronan HR Solutions Inc Full time

    Join the country's fastest-growing mental health practice group; now is the perfect time to join our corporate team. Our Accounting team is looking for a Payroll Sr. Accountant with high attention to detail, strong organizational skills, and be able to work in a fast-paced environment. In this role, you will participate in the month-end close process,...


  • Scottsdale, United States Axon Full time

    Your Impact As the Measurement System Specialist, you will Oversee, coordinate, and execute equipment and facility calibrations in accordance with QMS, ISO , and ISO Requirements. You will seize the opportunity to help drive world class quality systems that support our values, excite our customers, and achieve our mission to protect life. What...


  • Scottsdale, United States Brewer Morris Full time

    Responsibilities: Prepares basic to complex multi-state sales and use tax returns, environmental tire fee returns and other miscellaneous taxes using tax software systems; reconciles general ledger accounts; troubleshoots escalated issues. Analyze and evaluate transactional tax data to prepare reporting for various tax filings. Validates tax exempt...


  • Scottsdale, United States The Cigna Group Full time

    At Cigna, we're on a mission to improve the health, well-being, and peace of mind of those we serve. We're not just a health services company; we're innovators, dreamers, and doers who believe in the power of data and technology to transform lives. We're building a future where healthcare is personalized, proactive, and accessible. And now, we're venturing...

  • Tax Specialist

    4 days ago


    Scottsdale, Arizona, United States Jobot Full time

    Join Our Dynamic Team as a Tax SpecialistWe are a thriving CPA firm seeking a dedicated Tax Specialist to enhance our team. This position offers a unique opportunity to work in a supportive environment that prioritizes professional growth and development.About Us:Our firm is committed to delivering exceptional accounting, tax, and consulting services. We...