QA Auditor Ii Bioanalysis/formulation Analysis

5 days ago


Bengaluru, India Labcorp Full time

**Essential Job Duties**:

- Follow applicable policies and SOPs
- Navigate to the regulations and able read/understand specific regulations
- Perform review of protocols/amendments and report audits
- Timely notification to management regarding identification of critical issues
- Successful relationships on one-to-one basis. Able to answer questions relating to 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.

**Minimum Experience Required**:

- 2+ year in a regulatory environment
- ** QA Experience in review of Formulation analysis and Bioanalysis of GLP study samples preferred**
- ** Should be fine with working in 2nd shift hours ie., 2 PM to 11 PM IST**
- Ability to follow instruction e.g. QA documents (SOPs)
- Ability to assimilate/interpret operational documents such that audit can be
- performed to required level
- Adaptability to an ever changing work environment
- Ability to recognize gaps in procedures and regulations and consult with more
- senior QA individuals

**Recommended Education/Qualification**:

- A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
- Experience may be substituted for education.

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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