Clinical Quality Assurance Auditor
20 Firstfield Road Gaithersburg, MD 20878
We are seeking a Clinical Quality Assurance Auditor to join our Clinical Quality Assurance (CQA) Department. The qualified individual should have experience with US and international Good Clinical Practice (GCP) regulations, guidance documents, and industry best practice in the areas of a GCP environment.
Responsibilities include but are not limited to:
- Leads audits to ensure compliance to protocols, regulatory regulations, commitments, industry best practices and guidance' s.
- Conducts GCP audits in support of Clinical Study Teams, Clinical Sites and vendors.
- Conducts external laboratory audits (e.g. Immunology and specialty labs, academic labs and central diagnostic laboratories) to GCP, GCLP and best practices.
- Evaluates Clinical and Regulatory documents (e.g. protocols, amendments, Trial Master Files, Informed Consents, final reports, SOPs) for adequacy and compliance.
- Supports Clinical Trial Management, temperature excursion evaluation, vendor complaint process and risk management collaboratively; with routine management oversight.
- Author' s CQA SOPs and reviews Clinical Operations SOPs.
- Participates in CQA Internal Audit and Vendor Quality Programs
- Proficient knowledge of GCP, GCLP, GLP and cGMP.
- Provides training, guidance, and interpretation of regulations, GCP guidelines.
- Reviews, tracks and trends, routine quality data. Reports metrics and adverse trends to management with potential remediation plan for complex issues.
- Stays current with amendments to GXPs, including FDA, EU, and other regulatory bodies (relevant to NVAX activities) and guidance documents bodies to support NVAX' s clinical programs.
- Initiates and leads continuous quality improvement.
- Bachelor' s Degree or higher, in a related science field.
- A minimum of 5+ years in Clinical (GCP) Quality Assurance.
- Clinical auditing experience required.
- Strong knowledge of GCP regulations and minimum of 5 years in an auditing role.
- Experience with FDA ICH guidelines required.
- Good knowledge of GLP regulations and GCLP guidelines.
- Proficient in Microsoft Office suite (Access, SharePoint, Excel, PowerPoint and word).
- Ability to identify opportunities and changes in priorities making adjustments as needed.
- Ability to interact effectively and independently and within a group setting.
- Excellent multi-tasking, reasoning, trouble-shooting and root-cause analysis
- Reaches established goals/targets for moderately complex tasks with the involvement of teammates within commitments.
- Demonstrates flexibility in dealing with change and diversity.
- Individual must be willing to travel domestically and internationally (25 %+), as needed.