| Employer: | Nelson Labs |
| Job Location: |
Salt Lake City - Salt Lake County |
| Employment Type: | Full Time |
| Salary Range: | Salary is commensurate with education and experience. |
| Benefits: | Position includes a complete benefits package and excellent work environment. |
Description: |
Nelson Laboratories is a challenging and diverse organization. We are always looking for gifted, motivated individuals in highly specialized and business management roles in all parts of the company. If you are considering your future and are looking for somewhere to make a real difference, our company offers our employees many benefits and chances to move up within a growing industry.
JOB SUMMARY: The senior regulatory auditor is responsible for conducting internal and supplier audits in order to identify non-conformances to regulations and internal/external standards, and recognize opportunities for improvement based on risk to the company. The senior regulatory auditor also takes ownership of corrective and preventive action requests and investigations, and prepares quality system trend information for management review. The auditor is a mentor for other staff throughout these quality processes and assists with globalization of best quality practices.
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Duties: |
Internal/Supplier Audits
• Prepares audit agendas, makes assignments to audit team members, conducts audit, writes report, and ensures closure of issues.
• Review and ensure observations are properly classified with appropriate level of action based on risk to the company.
Trend Analysis
• Track, trend, and report quality system metrics to identify areas for improvement and assist in implementing actions if necessary.
Globalization of Quality Best Practices
• Assist in disseminating information about best practices, host discussions, and mentor staff.
Corrective and Preventive Actions
• Initiate, investigate, and administer corrective and preventive actions as necessary.
Regulatory Compliance
• Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc).
• Know and follow company policies and procedures.
Professional Development
• Complete required training in a timely manner (includes Master Control, live company trainings, New Employee Orientation, etc.)
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Qualifications: |
B.S. in a Biological Science, CQA and FDA auditing experience.
• Demonstrate in-depth knowledge of GMP, GLP, and ISO 17025 regulatory requirements
• Ability to effectively work with and support other members of staff and management with professional courtesy
• Ability to apply regulations in a valuable way to the company
• Ability to prioritize tasks from a risk-based approach and consistently meet deadlines
• Demonstrate knowledge of trend analysis to identify and act on recurring issues
• Ability to be proactive in continuous improvement of systems, processes, and procedures
• Must be solution driven
• Must have excellent response times and service for our clients and potential clients
• Ability to communicate internally and externally in a clear and objective manner
• Proficient in Microsoft programs and typing
Applicants must have at least two years of active auditing experience in a Microbiology, Pharmaceutical, or Medical Device setting.
Salary is commensurate with education and experience.
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