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.
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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 QA-to-QA 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 multi-regulatory 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: Bachelor's 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, 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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