Quality Assurance Specialist- Gmp/ Auditing

We are searching for a Quality Assurance Specialist for a niche company in the DMV area.

• This position is fully remote, but the candidate needs to live in Washington, DC. Virginia or Maryland. There is travel required for this role, which will be about 15% total. This travel will be local to the DMV area, as well as additional travel domestically and the possibility of international travel as well. Candidates much be able and willing to travel locally, domestically, and internationally.
• Keys to hire:
• 5+ years drug manufacturing experience, and also looking for at least 5+ years of solid GxP auditing

and Responsibilities

• Host client audits, perform external audits at clinical and/or vendor sites.
• Participate in the development Corrective and Preventive Action (CAPA) plans, and contribute to resolution of audit findings, under direct supervision of the Project Lead.
• Verify clinical compliance to applicable Standard Operating Procedures and regulations by performing audits.
• Assist with quality assurance (QA) audits (including document and process audits) per procedure.
• Assist with project management activities associated with quality projects, including maintenance of project information.
• Promote Quality by preparing Project Specific Procedures, providing training to staff and supporting the Quality Management System.
• Develop quality-related documentation for client projects, including SOPs, work practices, forms, training materials, etc., under the direct supervision of the Project Lead.
• Observe and adhere to applicable regulatory and legal requirements.
• Perform Quality Control (QC) of scientific documents and reports, as requested.

Requirements

• Prior experience in a Quality Assurance department required
• Provides oversight and development of Quality Management Systems (QMS)
• Bachelor’s degree in biomedical, nursing or related life science discipline required
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements
• 5 years of related experience or relevant pharmaceutical, health authority and/or CRO experience
• Understanding of scientific, medical, and/ or clinical data
• Familiarity with ISO 9001:2015