QA Auditor

QA Auditor

Our Labcorp site in Greenfield, IN, is currently recruiting for a Quality Auditor.  We are looking for someone with at least 3 years in a regulatory environment and/or BioPharma, Molecular Bio A expereince. You will perform quality audit reviews in molecular biology for clinical and 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 position is at the 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, where applicable for specific study types lead 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

• Provide consultation to the operational team (e.g. as they revise/write controlled documents)

• Delivery of training in performance of audits

• 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 responsibilities, as indicated in applicable controlled documents, are followed

Minimum Education and Expereince Requirements:

• Minimum: Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)

• Experience may be substituted for education

• 3 years in a regulatory environment

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

• Experienced GxP auditor

Preferred Qualifications:

• Experienced in process improvement

• 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

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. For more detailed information, please click 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 our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.