Sr. Specialist, Audit Program

 

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

 

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 or may be backroom support as needed, will ultimately be able to do both.  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: 

 

• Bachelor’s degree in engineering or similar degree, or equivalent work experience.
• Must have a minimum 5 to 8 years of relevant work experience.
• Strong analytical thinking and complex problem-solving skills
• ISO 13485 Lead Auditor certified.
• Experience working within FDA CFRs, ISO 13485, EU MDR or other regulated environments.