We are recruiting for a Quality Assurance Specialist to support our continued growth and on-going development projects. Qualified individuals need to have the capability, and desire to work with both the development of therapeutics (cGMP) and discovery research (non-cGMP) products and tools to support our innovative work. In this critical role you'll ensure implementation of Quality Management Systems and compliance with applicable regulations and guidelines, while reviewing records for accuracy and consistency with SOPs. In addition, you will support quality operations through review of documents and records, maintaining data integrity, disposition of materials, and providing cross functional Quality Assurance support. If you aspire to be a critical resource in creating and maintaining a culture of quality, compliance, and cost initiatives, we offer an exceptional and unique opportunity to fully develop your career potential.

Essential Responsibilities

1. Ensure data integrity through review of records generated in support of production and testing of product, verifying accuracy and traceability.
2. Review and release raw materials, intermediate products and finished products.
3. Review of documents and records used to support Good Manufacturing Practice and Discovery Research Operations, approving quality assurance records as appropriate.
4. Support CAPA, deviations, root cause analysis, nonconformance and investigations.
5. Ensure systems are compliant with current SOPs.
6. Assist investigations and resolve potential product quality issues.
7. Provide quality assurance support to organization.
8. Write, revise, review, and approve standard operating procedures.
9. Other job functions as assigned.

Required Skills and Education

• Bachelors degree in a life science discipline such as but not limited to cell biology, biochemistry, or microbiology, or its equivalent
• 3 years of relevant quality assurance experience with demonstrated achievements and progressive responsibilities.
• Demonstrated organizational; problem solving; decision-making; communication (oral and written); and influencing skills dealing with diverse stakeholders
• Detailed focused, with demonstrated writing skills using MS Office.
• Functional knowledge of cGMP principles and practices.
• Functional proficiency with an electronic Quality Management System
• Able to work at computer for extended periods of time