Job Description

Review of protocol, amendments 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.

Minimum Experience Required

4 years in regulatory environment (experience in GXP roles, preferably GLP)

QA or scientific experience in toxicology studies mandatory (in GLP environment)

Should be okay working in 2nd shift working hours ie., 2 PM to 11 PM IST

Knowledge of industry quality systems/standards and able to apply (applicable) regulations in order to monitor compliance

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

Recommended Education/Qualifications

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.

For more information about how we collect and store your personal data, please see our