QA Auditor GLPGCP
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Job Location:
Indianapolis, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
QA Auditor in Indianapolis IN.
Schedule: Monday Friday 8-5 pm
Job 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 Qualifications:
Minimum: Bachelors 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 GLP/GCP auditor
Preferred Qualifications:
Knowledge of auditing and techniques to monitor compliance
Experience in a Laboratory (GLP/GCP)
Additional Job Standards:
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
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) and Good Laboratory Practice (GLP) in the performance of their role
Labcorp is recognized as one of the worlds best employers and named as one of the most innovative companies. At Labcorp you will find a rewarding role that allows you to make a difference in peoples lives including your own!
Join an exceptional organization and an exceptional Quality department.
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 PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible toparticipatein the 401(k) Plan only. For 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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Required Experience:
IC
Key Skills
- Auditing
- Time Management
- ICD-10
- Accounting
- Component evaluation
- Workers' Compensation Law
- SOX
- Microsoft Excel
- CPT Coding
- Internal Audits
- Medicare
- Bookkeeping
About Company
Labcorp helps patients, providers, organizations, and biopharma companies to guide vital healthcare decisions each and every day.
