Pearl Therapeutics, an AstraZeneca group company, is developing unique dual and triple combination products for the treatment of widely prevalent respiratory diseases, including chronic obstructive pulmonary disease. Pearl's current focus is on making advanced inhaled therapies available to broad patient populations via familiar and accepted metered dose inhalers.
Auditor/ Sr. Auditor GCP QA and Compliance is responsible for independently performing various GCP audits both domestic and international. Incumbent provides hands-on execution of all aspects of quality assurance in support of Good Clinical Practice activities and providing quality oversight for Clinical Operations.
Conduct document reviews/audits of the following documents, but not limited to - clinical study reports (CSRs), NDA regulatory submission packages, informed consents, labels, package inserts, etc.
Assist in planning, scheduling and conducting domestic and international GCP audits such as routine clinical site and vendor audits, including CROs, internal GCP audits in accordance with company’s standard operating procedures.
Recommend corrective and preventative action of compliance issues. Implement corrective actions as determined through investigations and follow up on CAPAs implementation and effectiveness review. Monitor and track status of CAPAs to ensure that the issues are adequately addressed and completed.
Perform timely management of audit metrics and root cause analysis of non-compliances.
Represents the GCP Compliance group at clinical team meetings providing GCP subject matter expertise.
Assists in review of departmental SOPs and participate in the review/development of departmental SOPs, as appropriate.
Complete any other requests as assigned from management.
Assist in planning, scheduling and conducting pre NDA PAI readiness activities. Provide inspection support at clinical sites and for internal clinical team during Federal/regulatory inspections. Interacts with Federal/regulatory representatives during inspections.
This is a good opportunity for someone with regulatory experience who is looking to break into GCP auditing through this internship/contract.
A BS/MS in Life Sciences, Engineering, or equivalent.
5+ years of experience working in the pharmaceutical and/or biotechnology field operating under GxP regulations.
Clinical document review (5 years of experience min);
NDA regulatory submissions packages review (3 years of experience min);
Clinical (GCP) site auditing experience (2-3 years).
Demonstrated knowledge of GCP Quality Assurance activities and ICH and FDA/EU GxP regulations as they relate to clinical trials.
Basic understanding of statistical techniques in clinical trial reporting.
Exceptional interpersonal, problem-solving, and written/verbal communication skills
Must be proficient in MS Office Suite.
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