QA Auditor Toxicology

Greenfield, IN - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Our Labcorp site in Greenfield IN is currently recruiting for a Quality Auditor to support our toxicology team.

We are looking for someone with at least 2 years in a GLP regulatory environment. Experience with the FDAs Good Laboratory Practices 21 CFR Part 58 is strongly preferred.

Within the early development area: dose formulation dose analysis animal operations clinical pathology and anatomic pathology operations support pre-clinical studies.

We structure ourselves to deliver scientific expertise to our clients collaborating closely with them to support the development of medicinal products through the drug development process and onto the market.

This role supports the early development area as a Quality Auditor. You will perform quality audit reviews in pre-clinical studies. This position is at Greenfield IN. facility at 671 South Meridian Road (This position is not remote). This position is not eligible for visa sponsorship.

The individual in this role verifies compliance to standard operating procedures (SOPs) and regulations by performing study protocol data report and where applicable for specific study types participate in internal facility/process and/or supplemental inspections initiates and reviews SOPs and prepares and delivers training in performance of audits. The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job. It is the responsibility of all employees to comply with all applicable regulations e.g. Good Clinical Practice (GCP) Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) in the performance of their role.

Job Duties and Responsibilities:

Conduct but not limited to protocol review report/data audits and internal facility/process inspections

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

Peer review QA SOPs

Support operational liaison meetings representing QA function

Ensure Regulatory Compliance and Quality Assurance responsibilities as indicated in applicable controlled documents are followed

Minimum Education and Experience Requirements:

Minimum: Bachelors Degree in Life Sciences preferred (or equivalent Life Science experience)

Experience may be substituted for education

2 years in a GLP regulatory environment required and more GLP experience is a plus

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

Experienced GxP auditor

Able to interpret data and identify quality critical problems

Able to convey regulatory expectations

Preferred Qualifications:

Experienced in process improvement and quality auditing

Demonstrated ability to apply critical thinking skills

Clear communication skills including ability to provide clear feedback

Able to clearly articulate processes to provide training

Able to influence process improvement initiatives and offer solutions

Experience in an FDA 21 CFR Part 58 environment highly preferred

Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical Dental Vision Life STD/LTD 401(k) Paid Time Off (PTO) or Flexible Time Off (FTO) Tuition Reimbursement and Employee Stock Purchase Plan. Casual PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan more detailed information pleaseclick here.

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging 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 and merit of the individual. Qualified applicants will receive consideration for employment without regard to race religion color national origin sex (including pregnancy childbirth or related medical conditions) 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. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs or needs an accommodation please visit ouraccessibility siteor contact us at Labcorp Accessibility. Formore information about how we collect and store your personal data please see our Privacy Statement.

Our Labcorp site in Greenfield IN is currently recruiting for a Quality Auditor to support our toxicology team.We are looking for someone with at least 2 years in a GLP regulatory environment. Experience with the FDAs Good Laboratory Practices 21 CFR Part 58 is strongly preferred.Within the early de...