Biotechnology Quality Control Analyst
Vyriad is an early-stage biotechnology company focused on curing cancer using potent, safe and cost-effective cancer therapies utilizing engineered replication competent viruses designed to selectively and rapidly destroy cancer. Revolutionizing cancer treatment is our long-term goal, requiring curiosity, perseverance, an openness to challenging convention and a commitment to excellence. The challenges are complex, the work pace is fast, and progress is seldom a straight line. All of this makes for an exhilarating environment of collaboration, discovery, and fun.
Responsible for performing and validating analytical methods essential for quality control and release of drug product and performing environmental monitoring of critical manufacturing areas, thus ensuring that manufacturing processes and products meet quality specifications. The analyst shall maintain quality assurance processes, be responsible for testing products, recording, and analyzing data during product development and manufacturing. The analyst will follow through on set processes and ensures adherence to best production practices and product quality standards, as well as monitors the efficiency and cost-effectiveness of product output.
- Perform and maintain test systems for GMP manufacturing, and responsible for performing assays related to in-production and post-production product quality.
- Performs qualification/validation processes to maintain analytic validity of test methods.
- Monitor aseptic manufacturing suites for contamination.
- Maintain and monitor equipment and instruments, diagnoses, and troubleshoots minor issues with laboratory instruments and equipment.
- Monitor production processes for compliance with processes and procedures and participates in non-conformance and complaint investigations, and develops, coordinates, and implements corrective and preventive actions.
- Support other manufacturing work areas including supply chain staff in raw material inspections, maintenance of the supply records, supplier management program and recall activities, as needed.
- Assists Quality Assurance staff in collating records for the final batch record review, as needed.
- A bachelor’s degree in a science-related field is preferred, and a minimum of 3 years’ experience performing, and validating assays and/or working in a manufacturing quality control role.
Experience and skill requirement:
- Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing and testing is required.
- Additional experience with other requirements (Good Laboratory Practices, ISO, etc.) is highly desirable.
- Exceptional human relations and communication (written, verbal, and listening) skills are required.
- Should be very detail-oriented and have the ability to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment.
- Strong analytic skills coupled with critical thinking skills are essential in this role.
- Must have demonstrated capacity to write and comprehend complex protocols and reports, programs, and situations.
- The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required.
- Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.
- Full-time. Weekends or weeknight work occasionally required depending on production schedule or processes needs.
- Rochester, MN (Required)
- United States (Required)