Labcorp has a QA Compliance Auditor position in Indianapolis, IN. Join an exceptional team making a difference.
Do you have at least 4 years in a regulated environment and Auditing experience? Are you an experienced Chemist in the GxP regulatory environment and knowledgeable about ICH M10 methodology and method validation? This position is onsite at 8211 SciCor Drive, Indianapolis, IN and is Hybrid following training.
The individual in this role verifies compliance with standard operating procedures (SOPs) and regulations by performing study protocol, report/data, and in-lab phase audits where applicable for multiple business areas. The auditor leads internal and external facility/process and/or supplemental inspections, provides recommendations for improving compliance, 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.
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Job Duties:
- Conduct, but not limited to protocol review, single department report/data audits, in-lab phase audits where applicable for multiple business areas
- Development and delivery of training to operational groups
- Delivery of training in performance of audits
- Provide advice and guidance on aspects of quality and compliance
- Provide consultation to the operational team on quality issues
- Cross-site QA and operational relationship, provide recommendations for improving compliance and/or efficiency
- Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills]
- Manage local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization
- Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed
Minimum Education and Experience Required:
- Minimum: Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)
- Experience may be substituted for education
- 4 years in a regulatory environment (experience in GxP roles)
- Experienced GxP auditor
- Able to influence QA strategy
- Knowledge of industry quality systems/standards and able to apply (applicable) regulations to monitor compliance
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:
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. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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