About Meridian
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.
Job Summary
The Quality Control Analyst position performs testing and inspection of raw materials, in-process and finished products, and audits the corresponding documentation in compliance with internal SOPs and applicable regulatory requirements, participates in test method validation development and execution, and assists in the training and development of new Quality Control Analysts. The Quality Control Analyst is also responsible for performing duties required in the application and continued improvement of the company’s Quality System.
Key Duties
Tasks/Duties/Responsibilities:
- Write and revise SOPs or other controlled documents in accordance with applicable regulations
- Understand principles of Quality Management System, including requirements of Current Good Manufacturing Practice (CGMP), Good Documentation Practice (GDP), Good Laboratory Practice (GLP), Quality System Regulation (QSR), United States Department of Agriculture (USDA), and International Organization for Standardization (ISO) 13485
- Perform and document raw material, in-process, and final release testing utilizing, but not limited to, protein concentration determination (BCA and absorbance methods), enzyme-linked immunosorbent assay (ELISA), sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS-PAGE), high-performance liquid chromatography (HPLC), immunodiffusion, pH, and bioburden
- Perform data analysis of test results and review data for compliance to SOPs and specifications
- Perform weekly testing of facility purified water systems
- Maintain and organize laboratory supplies and QC retain inventories
- Maintain laboratory water monitoring and test sample tracking/trending logs
- Prepare assay reagents in accordance with applicable SOPs
- Perform laboratory maintenance and cleaning activities in accordance with applicable SOPs
- Participate in interdepartmental test method development and validation including assisting with drafting of technical transfer and assay validation protocols and reports
- In collaboration with Sr. QC Analysts, participate in evaluating, improving and/or optimizing existing QC test methods including design of experiments, execution of lab studies and revision of SOPs, as applicable
- Initiate and complete deviation reports
- Initiate and complete nonconforming product reports
- Initiate and complete out of specification (OOS) investigations and associated reports
- Assist and perform investigative testing activities as they relate to quality events
- Assist in the training and development of new Quality Control Analysts
- Work weekends and holidays, as neededUnderstand principles of Quality Management System, including requirements of Current Good Manufacturing Practice (CGMP), Good Documentation Practice (GDP), Good Laboratory Practice
- Performance of additional tasks as required
Qualifications
- Bachelor's degree in a scientific discipline or equivalent with a minimum of 2 to 5 years relevant experience
- Team-oriented individual with the ability to effectively participate as part of a team
- Proficiently works with all employee levels from executive management to line personnel
- Excellent written and oral communication skills
- Demonstrates ability to train others
- Highly organized and process oriented
- Able to work in a fast-paced environment
- Readily adaptable to changing demands
- Advanced computer literacy
- Proficient with statistical tools (e.g. Minitab software) and concepts and their application in a regulated environment
- Knowledge of cGMP, GLP, and ISO preferred
- Travel: 5%
*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*