QA Auditor

Company Name: PPD Development, L.P.

Location: 929 North Front Street, Wilmington, NC 28401

Employment Type: Full time

Work Schedule: Standard (Mon-Fri)

Location Type: Office

Environmental Conditions: Office

Position Overview

The QA Auditor is responsible for auditing laboratory data for GxP compliance with methods and standard operating procedures, reporting findings, and ensuring sample result tables and analytical reports are complete and accurately represent the data. This role serves as a resource to operational departments on audit and quality assurance matters, presenting findings and working with labs to resolve issues. The QA Auditor will also assess and resolve quality events, contribute to departmental metrics, and utilize Six Sigma concepts for process improvement.

Responsibilities

• Audit laboratory data for GxP compliance with methods and standard operating procedures.
• Report audit findings.
• Audit sample result tables and analytical reports for completeness and accurate data representation.
• Serve as a resource to operational departments on audit or quality assurance subject matter.
• Prepare and present audit findings and related information at departmental and internal operations meetings.
• Analyze situations and data requiring a review of various factors for problems of moderate scope.
• Develop professional expertise and apply company policies and procedures to resolve issues.
• Cooperate with colleagues to achieve deliverables.
• Apply company policies and procedures to resolve routine issues.
• Prepare audit findings and work with labs on resolving these findings.
• Assess and resolve quality events.
• Assist in preparing departmental metrics for quality council meetings.
• Initiate and lead practical process improvements using Six Sigma concepts and knowledge.
• Perform on-site In-Process audits according to SOPs and methods.
• Duties may be performed remotely.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field.
• Two (2) years of experience as a Pharmacy Intern, QA Manager, Customer QA Specialist, or related role.

Required Skills and Experience:

• Applicable GxP and appropriate regional regulations.
• Support, review, and revision of SOPs and WPDs.
• Analytical documentation regarding technical areas such as:
  • Flow Cytometry
  • Ligand Binding Assays
  • Liquid Chromatography
  • Simple medicinal compounding
  • Titration
  • 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
  • Quality Control Charts
• Regulatory Compliance techniques, including:
  • Regulatory Authority
  • Good Manufacturing Practice (GMP)
  • Good Laboratory Practices (GLP)
  • Good Clinical Practices (GCP)
• Auditing functions, including:
  • Planning
  • Preparation
  • Conducting Quality Audits
  • Data Collection
  • Analysis and Evaluation
  • Reporting
  • Follow-up
  • Closure

Experience with required skills may be gained from academic coursework or internships.

Company Information

Company Name: PPD Development, L.P.