Vyriad Rochester , MN 55905
Posted 1 week ago
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
Physical Requirements
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
Vyriad