Quality Auditor - GLP/GCP

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives.

Labcorp is seeking a Quality Auditor, GLP/GCP to join our team in Indianapolis, IN

Work Schedule: Monday Through Friday 8-5 pm

Job Responsibilities: The Quality Auditor plays a pivotal role as part of our Quality Assurance team in ensuring that clinical research laboratory testing operations comply with global regulatory standards and industry-recognized best practices, including GCP/GLP, ISO 15189, ISO 13485 and CAP.

Job Responsibilities:

• Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)

• Contributes to global QA policies on interpretation/ application of regulations

• Provide subject matter expertise to projects Support team in CAPA plan creation

• Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses

• Supports the QA–to-QA relationship with key client(s)

• Delivery of training in performance of audits (basic, intermediate, complex)

• Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization

• Supports the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings)

• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed

Minimum Qualifications:

• Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline

• 6 years in regulatory environment in GLP/GCP regulatory environment.

• 2 years of Auditing experience

• Postgraduate degree (MSC or equivalent) in science or management related discipline

Preferred Qualifications:

• Experience of industry quality systems/standards

• Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving

• Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios

Additional Job Standards:

• Ability to demonstrate effective communication verbally and written with an emphasis on strategic communication with clients.

• Excellent organizational and project management abilities.

At Labcorp, you can expect the following:

• Innovative Environment: Join a leading healthcare organization committed to driving innovation through internal development to help improve health and improve lives.

• Collaborative Culture: Work in a dynamic, inclusive environment that values diverse perspectives and fosters collaboration.

If you have a passion for compliance auditing and a drive for operational excellence, join our growing Quality team as a Quality Auditor and take your career to the next level at Labcorp.

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. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan. For more detailed information, please click here.

Labcorp is proud to be an Equal Opportunity Employer: