QA Auditor Iv

2 weeks ago

Bengaluru, India Labcorp Full time

Perform review of Protocols, SOPs and Reports
- Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution
- Report on relevant quality metrics (for multiple topics/departments) and highlight trends
- Provide consultation to the operational team (e.g. as they revise/write controlled documents)
- Delivery of training in performance of audits (basic, intermediate audit activities)
- Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills]
- Contribute to local Quality initiatives and process improvement initiatives aimed at improving compliance and/or efficiency of the local QA organization
- Create and/or re-write QA SOPs based on findings from local quality initiatives.
- Organizing, Prioritizing and Managing all aspects of workload to meet business needs.
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
- Perform other duties as assigned by management.

**Experience**:
Minimum Required:

- Min. 4 years in regulatory environment (experience in GXP roles)
- ** Okay to work in 2nd shift ie., 2:30 PM to 11:30 PM IST**:

- Experienced GxP auditor
- Experienced in process improvement
- 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
- ** Understanding of regulatory toxicology studies**

Education/Qualifications

Recommended:

- 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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