Quality Control and Analytical Assay Development Specialist
Reports to Director of Quality
The quality control and analytical assay development specialist is responsible for performing and validating analytical methods essential for quality control and release of drug product, as well as development and optimization of new analytical methods, and their validation, thus ensuring that manufacturing processes and products meet quality specifications. The specialist shall maintain quality assurance processes, be responsible for testing products, recording and analyzing data during product development and manufacturing. The specialist 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.
- Optimize and validate test methods for GMP manufacturing and process development.
- Responsible for writing protocols and reports for test methods.
- Perform and maintain test systems for GMP manufacturing, and responsible for performing assays related to in-production and post-production product quality.
- Perform 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.
- Assist 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 Requirements
- 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.
- Detail-oriented and possesses 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.
- Demonstrated capacity to write and comprehend complex protocols and reports, programs, and situations.
- Ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required.
- Flexibility to adapt to a variety of responsibilities, work assignments, and priorities.