Torque is seeking a highly motivated QA Sr. Specialist to support the delivery of our quality system to ensure clinical products are manufactured and distributed in accordance with all regulatory and corporate requirements. We're developing technologies for optimizing expression of tumor antigens as part of our best-in-class Slipstream™ T-cell manufacturing program.  The new hire will work collaboratively with internal stakeholders and external resource providers to improve the function of Torque's unique class of T-cell therapy. 

This individual will be the primary quality assurance representative on multiple Working Teams and is empowered to collaborate with key stakeholders for strategic Quality Assurance decisions including troubleshooting issues related to quality concerns, implementing effective solutions and corrective actions.

WHAT YOU'LL DO:

• Oversight & coordination of GMP Quality Systems and Policies for cGMP compliance
• Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and FDA guidelines
• Demonstrate a high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained
• Review of production records for compliance, assuring cGMP's and company procedures are followed and, if needed, procedures/policies are revised.
• Support of quality systems (Batch Record Review, Deviation, CAPA, Document review and approval, etc.) exercising judgment in selecting methods, techniques and evaluation criteria for obtaining positive results
• Work independently without appreciable direction and exercising latitude in determining objectives and approaches to assignments
• Ensure that practices are consistent with quality and regulatory standards 
• Support an environment of teamwork and collaboration

WHAT YOU'LL BRING:

• A minimum of a B.S. degree in science, engineering or equivalent with at least 5 years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environment
• Knowledge of FDA regulations and a working knowledge of root cause analysis
• Excellent interpersonal skills and the ability to communicate well orally and in writing
• Ability to multi-task in a fast-paced, dynamic environment with changing priorities
• Strong work ethic with the ability to meet challenging timelines
• Ability to think strategically and tactically, balancing these as workload changes

ABOUT US

Torque is an immuno-oncology company developing Deep Primed™ cell therapeutics with pharmacologic control to drive a full immune response within the tumor microenvironment. Our technology platform anchors powerful biotherapeutics—stimulatory cytokines, antibodies, and small molecules—to multi-targeted T cells to direct immune power locally in the tumor microenvironment.