Sr. Specialist, Audit Program

3 months 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

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