Quality Control Scientist
The Quality Control Scientist is responsible for scientific and technical aspects of drug product technology transfer, assay qualifications and validations, and analytical development. The Quality Control Scientist is responsible for releasing, researching, and developing new analytical processes to existing drug product (Voyager-V1), and pipeline assets, and making modifications to existing assays to improve overall efficiency towards commercialization. The Quality Control Scientist is involved in all aspects of quality control processes, from release to analytical development to raw material and stability program, including Environmental Monitoring.
Duties and responsibilities
Validate and maintain test systems for GMP manufacturing.
- Use technical experience to troubleshoot issues with drug product analytical technologies and equipment.
- Serve as a subject matter expert to support quality control operations.
- Leads investigations and resolve potential product quality issues to improve efficiency.
- Drive continuous improvement in cGMP process steps through technological innovation and application of experimental findings.
- Collaborate in development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of products.
- Provide technical representation during internal and external audits.
- Collaborate in the setting of specifications and identification of appropriate drug substance and drug product testing.
- Analyzes and interprets data as it pertains to quality specifications.
- Keeps up to date with current technologies and trends in drug product processing.
- Responsible for accurately documenting results of all assays performed.
- Responsible for maintaining the laboratory in an orderly, organized and sanitary manner.
- Performs qualification/validation processes to maintain analytic validity of test methods.
- Notifies management when unexpected/out-of-specification results of analytical tests.
- Perform any other related duties as assigned.
Perform and maintain environmental monitoring program and gowning qualifications.
- Responsible for collecting environmental monitoring samples.
- Conducts gowning qualification testing of staff that enter the manufacturing suites.
- Performs microbiology analysis of microbiological culture plates.
- Analyze and trend environmental monitoring and gowning qualification data.
Maintain and monitor equipment and instruments used in production.
- Performs quality control, preventive maintenance and calibration of laboratory instruments and equipment.
- Responsible for the safe, reliable, and efficient operation of laboratory instruments and equipment.
- Diagnoses and troubleshoots issues with laboratory instruments and equipment.
- Provides support as needed for on-site assessments.
Education and experience
- Advanced degree (Ph.D. and/or relevant degree highly desirable) and 5-6 years of related work experience.
- Minimum of 4 years working in biologics drug product quality control role.
- Experience with setting up, supporting, and troubleshooting multiple pieces of drug product analytical equipment.
- Experience conducting process characterization, analysis and development with minimal supervision.
- Experience supervising junior quality technical staff.
- Previous experience with FDA current Good Manufacturing Practices, European Union regulations, and/or ISO certification for product manufacturing is highly desirable.
- Prolonged periods of standing at laboratory benches.
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.