Quality Control Analyst

Meridian Bioscience, Inc.•Memphis, TN

About The Position

The Quality Control Analyst performs testing and inspection of raw materials, in-process materials, and finished products, and audits related documentation for compliance with internal SOPs and applicable regulatory requirements. The role participates in developing and executing test method validations and helps train and develop new Quality Control Analysts. It also supports the application and continued improvement of the company’s Quality System. The analyst prepares and maintains controlled documents, performs and documents laboratory testing, analyzes results, and conducts investigations and testing related to quality events. The role also helps develop, validate, evaluate, and improve QC test methods in collaboration with other departments and Senior QC Analysts. Weekend and holiday work may be needed.

Requirements

Bachelor's degree in a scientific discipline or equivalent, with 2 to 5 years of relevant experience.
Ability to participate effectively as part of a team.
Ability to work with employees at all levels, from executive management to line personnel.
Excellent written and oral communication skills.
Ability to train others.
Highly organized and process oriented.
Ability to work in a fast-paced environment and adapt to changing demands.
Advanced computer literacy.
Proficiency with statistical tools, such as Minitab, and statistical concepts and their application in a regulated environment.

Nice To Haves

Knowledge of cGMP, GLP, and ISO.

Responsibilities

Write and revise SOPs and other controlled documents in accordance with applicable regulations.
Perform and document raw material, in-process, and final release testing using applicable laboratory methods, including BCA and absorbance methods, ELISA, SDS-PAGE, HPLC, immunodiffusion, pH, and bioburden testing.
Analyze test results and review data for compliance with 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 and 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 technical transfer and assay validation protocols and reports.
Collaborate with Senior QC Analysts to evaluate, improve, or optimize existing QC test methods, including designing experiments, conducting laboratory studies, and revising SOPs as applicable.
Initiate and complete deviation reports, nonconforming product reports, and out-of-specification investigations and associated reports.
Assist with and perform investigative testing related to quality events.
Assist in training and developing new Quality Control Analysts.
Work weekends and holidays as needed.
Perform additional tasks as required.