Covance Senior QA Compliance Auditor in San Diego, California
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 GCP 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
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.
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