QA Auditor

10 hours ago

Bengaluru Karnataka, India Labcorp Full time

The job will involve:
Conducting regulated study protocol reviews, data and report audits for Toxicology and supporting Dose Analysis Analytical chemistry audits
- Follow applicable approved policies and SOPs
- Navigate to the regulations and able read/understand specific regulations
- Perform review of protocols/amendments and report audits.
- Timely notify management regarding identification of critical issues.
- Able to understand regulatory requirements and issue audit findings (successful interaction/relationships on small scale outside QA function)
- Make suggestions for improving compliance and/or efficiency of the local QA
- organization and business units supported
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
- Other duties as assigned by management.

**Experience**:

- A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
- 2+ year in a regulatory environment
- QA Experience in GLP Toxicology studies on small animals/non-rodents and/or Dose formulation analysis preferred along with understanding of importance of concentration analysis in GLP study
- Experience in regulatory environment as GLP QA Auditor roles desired.
- Experienced in inspecting and auditing animal Toxicology and supporting dose analysis analytical part.
- Clear communication skills, including ability to provide clear feedback.
- Able to clearly articulate processes in order to provide training.
- Able to influence process improvement initiatives / offer solutions.
- Should be fine with working in 2nd shift hours i.e., 2:30 PM to 11:30 PM IST

**Labcorp is proud to be an Equal Opportunity Employer**:
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