QA Auditor Ii- Bioanalysis/formulation Analysis

2 weeks 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, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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