Quality Control Analyst

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

• Write and revise SOPs 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, endotoxin analysis, 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 laboratory supplies inventory.
• Maintain laboratory environmental 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 test method development and validations.
• Provide input into improving and/or optimizing existing QC test methods.
• Initiate and complete deviation reports.
• Initiate and complete out of specification (OOS) investigations and associated reports.
• Assist in the training and development of new Quality Control Analysts.
• Work weekends and holidays, as needed.
• Performance of additional tasks as required.

Knowledge, Skills and Abilities:

• Demonstrates proficiency with protein assays, ELISA, SDS-PAGE (Coomassie Stain, Silver Stain, Western Blotting), endotoxin analysis, immunodiffusion, HPLC, pH, and bioburden analysis.
• Excellent working knowledge of CGMP, QSR, GLP, and ISO regulations.
• Proficient in Microsoft Word and Excel.
• Practical knowledge of assay control and standard management and qualification.
• Ability to conduct product or process investigations.
• Experience with Out of Specification procedures is preferred.
• Ability to interact in internal and external audits.
• Detail and process oriented

Qualifications

Education and Experience:

• Bachelor's degree in a scientific discipline or equivalent with a minimum of 0 to 1 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 and concepts and their application in a regulated environment.
• Knowledge of cGMP, GLP, and ISO preferred.

Requirements:

• Travel

• 5% domestic travel, as required.

• Physical
• Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility.
• Must be able to analyse and solve complex issues throughout the course of the workday.
• Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the work day.
• Must be able to lift up to 30lbs. multiple times daily.
• May be required to work outside normal business hours including evenings and/or weekends to support business needs.