QA Auditor II - Toxicology

The job will involve:

• Conducting regulated study protocol reviews, data and report audits for Toxicology, Safety Assessment and Pharmacology studies.
• Conducting internal (study, process, facility based) inspections.
• Reviewing Standard Operating Procedures.
• Development and delivery of training to operational groups and QA.
• Provide advice and guidance on aspects of quality and compliance.
• Cross-site QA and operational relationship, provide recommendations for improving compliance and/or efficiency
• Working with operational management to support Quality topics and/or working on projects with QA team on other sites
• Managing local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization
• Ensuring Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed 

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
• Experience in regulatory environment as GLP QA Auditor roles desired.
• Experienced in inspecting and auditing animal Toxicology, Safety Assessment or Pharmacology studies and processes is desired, but not necessary.
• Experienced using data collection systems such as Pristima and Veeva, but not necessary.
• Knowledge of the OECD GLP quality systems/standards and able to apply regulations in order to monitor compliance.
• 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.
• Should be fine with working in 2nd shift hours ie., 2:30 PM to 11:30 PM IST

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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