Compliance Auditor II – Internal Audits
- Interpret the GMP regulations / guidelines and the Company Quality Standards and ensure that the site remains compliant with these requirements.
- Ensure realization of the site audit plan by conducting internal audits and inspections and ensuring the follow-up on corrective actions.
- Report findings in a clear, precise and factual way.
- Suggest and evaluate changes to the site's quality system.
- Work closely with departments outside QA to improve overall quality and make sure that site personnel are properly trained / qualified to perform their assigned duties.
- Contribute to the continuous improvement of the internal processes and may be asked to participate in Quality related Project teams.
- Perform internal audit, write audit reports, and follow-up on audit responses and corrective actions.
- Remain up-to-date on current Regulatory trends (Regulatory Observations, New Regulations/Guidelines) as well as Company Quality Standards.
- Follow up of action items generated from internal Audit & Walkthrough audits.
- Perform site specific supplier audits as needed.
- Other duties within the quality department as required.
- Bachelor's degree in a technical field i.e. Biology, Chemistry, Engineering, Pharmacy and a minimum of four years related experience or equivalent combination of education and experience.
- Current ASQ CQA certification or ISO certification or equivalent auditor certification.
- 5 -7 years of experience in a pharmaceutical production, medical device, and/or combination product environment.
- 5 - 7 years of experience in auditing with GMP regulated industries required.
- Must have Aseptic Manufacturing experience.
- Microsoft Office Applications – Word, Excel, Access, PowerPoint, Outlook, Visio, etc.