About the Company
Our client, a biopharmaceutical company focused on the discovery and development of novel therapeutics for intractable diseases, is currently seeking a Quality Assurance Specialist to join their team.
The QA Specialist will serve as the primary quality assurance resource for problem identification, resolution, loss reporting and continuous improvement and is responsible for ensuring GXP compliance internally and externally to the organization with contracted service providers. Key responsibilities include:
- Managing, coordinating, facilitating and implementing quality assurance standards based on ICH, European and FDA requirements.
- Writing quality assurance SOPs and policies and developing and controlling early stage quality programs
- Monitoring contractor/CRO conformance with QA standards and procedures and setting their direction for regulatory compliance.
- Providing guidance to in-house individuals and teams on Quality policy as it relates to their job.
- Tracking, coordinating and participating as necessary in qualification or audit process of vendors and CSPs.
- Performing batch record review and approval.
- Performing quality function in eDMS (Workflow Coordinator in GXP workflows) to author, review and approve Standard Operating Procedures and associated documents.
Share This Position:
- Bachelor’s degree in Biomedical, Biology, Chemistry or Molecular Biology & 5 years’ experience in Quality Systems, Quality Assurance and/or Quality Control in Pharmaceutical or Biotech field
- Certification in Quality Assurance (pharmaceutical)
- GLP compliance experience
- GXP in-house training experience
- Strong technical writing ability
- Experience with US regulations for early stage product, including GCP and GMP