DescriptionAre you passionate about making a tangible impact in the clinical technology 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:- Client Audit Planning, Hosting and Report Responses.
- Ensuring all client findings are addressed and closed by targeted due date.
- Provide guidance for issue resolution as applicable
- Conduct lessons learned with auditees, as appropriate, after audit completion.
- 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 audits for trends. Work with the Quality Audit Manager for audit reporting and escalations to Quality Management.
- Participate in all regulatory inspections.
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 SOPsRequirements- A minimum of 6-8 years' experience as an client audit host in a regulatory environment.
- 3-5 years' experience 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 Certificate Requirements- A bachelor's degree in a life sciences or information technology field, or equivalent auditing experience is preferred.
- Membership in professional organizations such as the Society of Quality Assurance (SQA), American Society for Quality (ASQ), or Regulatory Affairs Professionals (RAPS) certification desired.
Compensation: $89,000 - $105,000The salary range listed above represents a
good-faith estimate of the base pay for this role and is provided to comply with applicable laws and regulations. The actual base salary offered will depend on factors such as the candidate's
location, qualifications, experience, and skills