Quality Control Analyst

Meridian Bioscience • Memphis, TN

2d

About The Position

The Quality Control Analyst performs testing and inspection of raw materials, in-process materials, and finished products, and audits associated documentation in compliance with internal SOPs and applicable regulatory requirements. The role participates in test method development and validation, helps train and develop new Quality Control Analysts, and performs duties that support the application and continued improvement of the company’s Quality System.

The position works with regulated laboratory processes and quality requirements, including CGMP, GDP, GLP, QSR, USDA, and ISO 13485. It also involves laboratory maintenance, inventory and sample tracking, quality-event investigations, and collaboration with other departments on test method development and optimization. Travel is 5%.

Requirements

• Bachelor’s degree in a scientific discipline or equivalent, with 2 to 5 years of relevant experience.
• Team-oriented, with the ability to participate effectively as part of a team.
• Able to work effectively with employees at all levels, from executive management to line personnel.
• Excellent written and oral communication skills.
• Demonstrated ability to train others.
• Highly organized and process-oriented.
• Able to work in a fast-paced environment and adapt readily to changing demands.
• Advanced computer literacy.
• Proficient 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 methods including protein concentration determination (BCA and absorbance), 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 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, and optimize 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 related 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level