What are the responsibilities and job description for the Senior Quality Auditor (Hybrid Role) position at 4g Clinical, LLC?
Are you passionate about making a tangible impact in the clinical research field? Do you thrive in dynamic environments where problem-solving and innovation are encouraged? If so, we have an incredible opportunity for you to consider.
We are currently seeking a talented individual to join our Quality team as a Senior Quality Auditor.
The Senior Quality Auditor is responsible for the following:
- Planning, conducting, and reporting of internal audits assigned per the quarterly audit schedule or requested by Quality Audit Lead or Quality Management.
- Conduct internal audits of all corporate products and areas related to 4G Clinical’s product and services offerings, including but not limited to: product development life cycle, study development life cycle, training, client studies, data audits, product releases, and change control.
- Provide guidance for issue resolution as applicable, and work with Computer Systems Validation (CSV) group to ensure resolutions include maintaining the validation of products and studies.
- Conduct lessons learned with auditees, as appropriate, after audit completion.
- Audit to regulations, procedures, and industry best practices.
- Prepare audit reports and certificates.
- Provide mentoring to junior auditors.
- Participate in continuous improvement of 4G Clinical procedures and overall quality system.
- Monitor and analyze results of internal audits for trends. Work with the Quality Audit Lead for audit reporting and escalations to Quality Management.
- Assist in hosting client audits and participate in all regulatory inspections.
Required Experience
The position requires a minimum of 5 years’ experience as an auditor in a regulatory environment. Three years of auditing experience of Computer Systems Validation and RTSM experience is desired. Skills in audit planning, audit conduct, and audit management are essential.
Education and/or Certifcate Requirements
The candidate must possess a bachelor’s degree in a life sciences or information technology field, or equivalent auditing experience.
Membership in professional organizations such as the Society of Quality Assurance (SQA), or Regulatory Affairs Professionals (RAPS) certification desired.
This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs
