QA Auditor

Work Schedule

Environmental Conditions

Job Description

Company Name:                                              PPD Development, L.P.

Position Title:                                                   QA Auditor

Location:                                                           929 North Front Street, Wilmington, NC 28401

Summary of Duties: Audits laboratory data for GxP compliance with methods and standard operating procedures and report findings. Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings. Serves as a resource to operational departments on audit or quality assurance subject matter. Prepares and presents audit findings and/or other related information at departmental and internal operations. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Develops professional expertise, applies company policies and procedures to resolve a variety of issues, cooperating with colleagues to reach deliverables. Applies company policies and procedures to resolve routine issues. Prepares of audit findings and/or other related information and work with lab on resolving these findings. Assesses and resolves quality events. Helps prepare departmental metrics to be presented in the quality council meetings. Uses six sigma concept and knowledge to initiate and lead practical process improvement. Perform on site In-Process audit according to SOP and methods. Duties may be performed remotely.

Qualifications: Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field and two (2) years of experience as a Pharmacy Intern, QA Manager, Customer QA Specialist, or related role. Must have any amount of experience with: Applicable GxP and appropriate regional regulations; Support, review and revise SOPs and WPDs; Analytical documentation regarding technical areas, such as Flow Cytometry, Ligand Binding Assays, Liquid Chromatography, simple medicinal compounding, titration, or analytical testing; Quality Management System techniques including Quality Assurance (QA), Quality Control (QC), Standard Operating Procedure (SOP), Batch Record, Calibration, Validation, Documentation, Non-conformance, non-compliance, Corrective Action/Preventive Action (CAPA), Audit, Risk Assessment, and Quality Control Charts; Regulatory Compliance techniques including Regulatory Authority, Good Manufacturing Practice (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP); Auditing functions including Planning, Preparation, Conducting Quality Audits, Data Collection, Analysis and Evaluation, Reporting, Follow-up and, Closure. Experience with required skills may be gained from academic coursework or internships.