Job Description / Summary

The Quality Assurance (QA) Consultant provides specific subject matter expertise in the areas of Quality Assurance in support of InClin GxP projects, Quality operations, including, but not limited to supporting Quality System development/process development and implementation, Regulatory Compliance Assessments, Mock Competent Authority Inspections, and Management of Regulatory Inspections, remotely and/or in-person. The QA Consultant will support InClin Quality projects as assigned.

RESPONSIBILITIES

The main responsibilities of this role include but are not limited to the following:

• Provide guidance and expertise to the InClin and Client teams, based on the QA Consultant’s area of education, experience and training
• Conduct and/or support systematic and independent assessments and mitigation strategy plans, as assigned
• Provide industry expertise and guidance on continuous improvement projects, as applicable
• Support, conduct, and procure audit reports, prepare, write fit-for-purpose inspection/audit observations and responses, as assigned
• Provide ad hoc consulting, recommendations and risk mitigation support, as applicable
• Conduct laboratory, validation document, Trial Master File reviews and assessments and/or Quality Assessments, as assigned
• Support and actively participate on Inspection Readiness projects and responsibilities, as assigned
• Attend project meetings as scheduled by the project team
• Support Inspection Management Training, as assigned
• Support/manage compentent authority inspections

EDUCATION AND EXPERIENCE REQUIREMENTS

• Bachelor’s degree or equivalent experience required (scientific or healthcare discipline preferred)
• Minimum of five (5) years’ experience in area of expertise

KNOWLEDGE & SKILLS REQUIREMENTS

• Hands-on experience and knowledge in supporting all phases of drug development in specific areas of expertise
• Ability to effectively build strong working relationships with internal and external team members, as applicable
• Robust knowledge of GxPs; e.g., ICH, FDA, EMA, etc. in the area of expertise
• Strong technical writing skills and oral communications
• Demonstrated ability to work independently in a fast-paced, multi-project environment
• Ability to travel both domestic and internationally, as assigned
• Maintains a high regard for integrity, ethical conduct, and confidentiality in support of quality-based outcomes