Regulatory & Quality Compliance Specialist (Auditor)
The Regulatory & Quality Compliance Specialist (Auditor) is responsible for providing oversight of internal/external and regulatory agency audits and working to ensure compliance with Swiss American Products procedures, ISO standards and FDA and global laws and regulations.
Essential Duties and Responsibilities:
Prepare, host and respond to Regulatory Agency audits and customer audits.
Schedule, conduct and follow up of internal audits.
Schedule, conduct and follow up of external supplier audits.
Responsible for working with other employees to resolve compliance issues as appropriate.
Initiate all CAPA found during internal, external and third-party audits.
Follow up with personnel on CAPA reports assigned due to audit.
Develop standard tools and procedures to improve audit efficiency.
Evaluate and enhance audit procedures to ensure compliance with cGMP, global regulatory requirements and company policies when necessary.
Assist in data analysis and preparation of Management Review reports.
Attends and participates in meetings as required.
Bachelor’s Degree in a scientific discipline.
Minimum 5 years’ experience as a Compliance Auditor.
Attention to detail is critical.
Auditor certification preferred (ASQ, RAPS, etc.).
Strong working knowledge of current Good “X” Practices (cGxPs), Food and Drug Administration (FDA), ISO 13485 and other global regulatory requirements.
Travel required approximately 30% of the time.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive annual salary, an extensive benefits package including paid time off, medical, dental and vision benefits, 401K plan with company match and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, and culture.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.