Covance by Labcorp is seeking candidates for a Senior QA Compliance Auditor. The Senior QA Compliance Auditor will be remotely (home-based) located anywhere within the United States.
- 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 QA–to-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.
- Other duties as assigned by management.
- Travel up to 50% with respect to any pandemic-related restrictions.
- A minimum of a Bachelor's Degree in a 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 regulatory environment (experience in GXP roles).
- 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.
- Phase II to IV experience
- Investigator site audit experience
- GCP QA experience
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