An industry-leading biotechnology company with a team of over 20,000 professionals specializing in the discovery, development, manufacturing, and commercialization of top-of-the-line drug products for cancer and primary progressive multiple sclerosis is seeking a qualified Quality Assurance Specialist to join their team. The QA Specialist will oversee change control and document management for Investigational Medicine Product partners (IMP) partners. The individual will also provide Quality Systems support and participate in continuous improvement initiatives.
This role is ideal for those who thrive in a collaborative and cross-functional environment, would like to get a foot in the door with a giant in the industry, or seek to develop their skillset and career alongside other quality professionals, scientists, engineers, and regulatory professionals. This is a 6+ month contract to start with extensions and/or direct-hire opportunities.
- Oversee Quality System and manage change control and documentation within GMP standards and specifications for IMP Small Molecule and Biologics.
- Support internal inspections and audits for IMP partners.
- Support continuous improvement of Quality System SOPs, processes, and tools.
- Identify and resolve Quality issues in a collaborative environment.
- Support project team members with local and cross-functional projects.
- Perform other tasks related to Quality oversight.
- B.A/B.S degree in Biology, Chemistry, Engineering, or similar.
- 6+ years of QA, QC, or Manufacturing experience in the pharmaceutical/biotech industry.
- Working knowledge of US, EU and global cGMP requirements.
- Strong foundation in Quality Systems for IMP Small Molecule and Biologics products.
- Experience with Quality System software (i.e., Veeva QMS, SAP, LIMS).
- Highly detail-oriented, collaborative, and results-driven mindset desired.
*This is a 6+ month contract to start with extensions and/or direct-hire opportunities.
US Authorized workers only.