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Job Description

Overview:

Insight Global is looking for a Audit Specialist to join one of our largest medical manufacturing companies in the Pittsburgh area. This resource will be joining the Corrections and Removals team operating under an active consent decree, your role is critical in ensuring strict compliance with the terms outlined in the decree. Your primary responsibility is to conduct internal audits to assess the company's adherence to the requirements specified in the consent decree and to drive ongoing improvements to achieve full compliance. In this role, meticulous attention to detail, a deep understanding of regulatory requirements, and the ability to drive organizational change towards sustained compliance are paramount.

Day to Day:

- Conducting Compliance Audits: Performing thorough audits of the company's operations, documentation, and quality systems to validate adherence to the terms of the consent decree.

- Monitoring Compliance: Continuously monitoring and evaluating the company's activities to ensure alignment with the requirements of the regulators.

- Identifying Areas for Improvement: Identifying any areas where the company may be at risk of non-compliance with the consent decree terms and working proactively to address these issues.

- Developing Corrective Action Plans: Collaborating with relevant departments to develop and implement corrective action plans to rectify any compliance deficiencies identified during audits.

- Documenting Compliance Efforts: Maintaining detailed records and reports of audit findings, corrective actions taken, and progress towards meeting the requirements of the consent decree.

- Educating Employees: Providing training and guidance to employees on the specifics of the consent decree requirements and promoting a culture of compliance throughout the organization.

- Engaging with Regulatory Bodies: Serving as a point of contact for interactions with regulatory bodies overseeing the consent decree, ensuring transparency and timely communications.

- Risk Management: Conducting risk assessments to identify and mitigate potential compliance risks that could impact the company's efforts to fulfill the terms of the decree.

- Collaboration and Communication: Working closely with cross-functional teams to ensure alignment and coordination in addressing compliance issues and implementing improvements.

- Continuous Monitoring: Establishing mechanisms for ongoing monitoring and verification of compliance measures to track progress and maintain a state of continual readiness.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .

Skills and Requirements

- Bachelors Degree (ideally computer science or data science)

- 5+ years of experience within regulatory environment

- Pharmaceutical background / environment

o Knowledge of 21 CFR 806 & 21 CFR Part 7 - Experience working with Regulators or Notified Bodies (The FDA) null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.