Quality Auditor GLPGCP

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 worlds 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 youll have the opportunity to do meaningful work grow your career and make a real impact on peoples health around the world. Together were 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 QAto-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:

• Bachelors 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 regularly scheduled to work less than 20 hours Casual Intern and Temporary employees are only eligible to participate in the 401(k) 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

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