• Quality Assurance Assistant

    Cook Medical (Pittsburgh, PA)


    Overview

     

    Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

     

    The Quality Assurance Assistant at Cook Myosite, Inc. performs record review of quality records and provide general support to QA team and QA Management.

    Responsibilities

    • Print and issue batch records• Review completed batch records, associated forms, and general forms for accuracy, completion, and GMP documentation.• Review and approve documentation associated with Biopsy receipt• Review and approve documentation associated with incoming materials• Compile and/or review data compiled for reports.• Maintain spreadsheets and databases using Excel and Access• Clerical functions such as printing, scanning, and filing of QA records and documentation• Assist with process improvement projects• Assist with training of other QA team members• Perform various computer applications on MS Office programs

    Qualifications

    • Associates degree in Life Sciences, Biomedical or related fields or 4 years of direct, relevant experience in cGMP environment to provide a comparable background

    • Minimum of 1-3 years' experience in cGMP background

    • Knowledge of cGMP regulations and good documentation practices

    • Proficient knowledge of Microsoft Office software, and other general office equipment.

    Physical Requirements:

    • Hybrid position

    • Laboratory Setting (Non-Production): General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.

    • Ability to conduct and hear ordinary conversation and telephone communication.• 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.• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.• Visual and manual acuity for working with computers and equipment.• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting.• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.• Must be able to lift/push/pull up to 50 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 facial mask (if required) on a regular basis.• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.

     

    Requisition ID2025-16753

     

    Posting Date6 days ago(5/30/2025 5:07 PM)

     

    Job Location(s)Pittsburgh PA United States

     

    Job LocationsUS-PA-Pittsburgh

     

    Position TypeFull Time

     

    CompanyCook Myosite Inc.

     

    CategoryQuality