Quality Assurance Assistant

4 months ago
Requisition ID
Job Location(s)
Pittsburgh PA United States
Position Type
Full Time
Cook Myosite Inc.


The Quality Assurance Assistant at Cook Myosite Inc. performs detailed quality reviews of batch records and associated records ensuring compliance with procedural and regulatory requirements.


• Performs quality inspection and documentation for incoming biopsies
• Reviews records and associated data in support of cGMP operation activities
• Performs quality reviews of batch records and responsible for assigning the appropriate disposition instructions
• Creates batch records, product labels and performs label verification processes
• Responsible for identifying and initiating deviations and assists with investigation report writing, as needed

• Participates in company projects as a quality representative
• Performs various office-related duties; filing, scanning, and data entry
• Promotes GLP/cGMP environment and follows procedural guidelines


• Bachelor’s degree in Life Sciences discipline or equivalent
• At least 2 years of relevant experience in QA or equivalent
• Knowledge of cGMP regulations and good documentation practices preferred
• Demonstrates excellent problem solving and critical thinking skills
• Ability to work independently, within prescribed guidelines, or as a team member
• Detailed oriented and good written and oral communication skills
• Must be familiar with Microsoft Office applications


Physical Requirements:

• General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II

• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time
• Ability to spend majority of day standing in warehouse setting or sitting in biological safety hood setting
• Ability to conduct and hear ordinary conversation and telephone communication
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations
• Visual and manual acuity for working with computers and equipment

• Must be able to lift/push/pull up to 25 pounds on an occasional basis with or without reasonable accommodations
• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on a regular basis
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required
• Ability to work under specific time constraints


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