QA Auditor - Toxicology

LabCorp • Greenfield, IN

63d • Onsite

About The Position

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 FDA's 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.

Requirements

• Minimum: Bachelor's 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

Nice To Haves

• 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

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

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 only.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Ambulatory Health Care Services
• Number of Employees: 5,001-10,000 employees