Senior QA Compliance Auditor
Senior QA Compliance Auditor
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Job Description
Senior QA Compliance Auditor
Labcorp has Senior QA Compliance Auditor positon in Greenfield IN. We are looking for someone with knowledge and experience with DART studies and in mentoring and development. Do you also have strong Issue Resolution skills and experience then this is the position for you. Please Apply!
The individual in this role verifies compliance with standard operating procedures (SOPs) and regulations by performing all types of inspections/audits. The auditor hosts external audits/inspections assists with the facilitation of audit responses 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.
Duties and Responsibilities:
Conducts all types of inspections/audits hosts external audits/inspections and assists with the facilitation of audit responses and prepares and delivers training in performance of audits
Contributes to global QA policies on interpretation/ application of regulations
Support review of SOP quality agreements and supplier assessments
Provide subject matter expertise to projects
Support team in CAPA plan creation
Supports the QAtoQA relationship with key client(s)
Delivery of training in performance of audits (basic intermediate complex)
Participate in global quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization (for multiregulatory topics in area of expertise)
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 responsibilities as indicated in applicable controlled documents are followed
Minimum Education and Experience Required:
Minimum: Bachelors Degree Pharmacy Chemistry or Biology related discipline
Postgraduate degree (MSC or equivalent) in science or management related discipline preferable
Experience may be substituted for education
6 years in a regulatory environment (experience in GxP roles)
Able to influence QA strategy
Knowledge of industry quality systems/standards and able to apply (applicable) regulations to monitor compliance
Skills and Competencies:
Knowledge/experience with DART studies
Experience in mentoring and development
Issue Resolution skills/experience
Knowledge of multiple operational areas
Excellent interpersonal/organizational skills e.g. communication decision making negotiating problem solving
Able to clearly articulate processes to provide training
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 pleaseclick 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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Required Experience:
Senior IC
Employment Type
Full-Time
