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    Quality Assurance Specialist - Omaha, United States - Insight Global

    Insight Global
    Insight Global Omaha, United States

    2 weeks ago

    Insight Global background
    Pharmaceutical / Bio-tech
    Description

    Opening: Sr. QA Specialist

    Type: 12M CTH

    Up to 50/hr

    Locations: Omaha, Nebraska – Must be onsite

    Must Haves:

    • 5-7+ years experience within QA
    • Experience working in a regulated industry (Pharma, Clinical, Manufacturing, Food etc.. FDA/USDA)
    • 4 year degree in a science related field
    • Must have experience working with Antigens
    • Strong understand on assisting with Blue Prints and Legend Updates
    • Previous experience working with p-FMEA and other assessments for both manufacturing and testing
    • Strong documentation experience creating/reviewing/updating SOPs

    Plusses:

    • Working at a USDA facility
    • Understanding of working with CAPA management Background in Project Management
    • Knowledge of working with data/statistics/deviations
    • Previous experience working on an antigen transfer project

    Day to Day:

    Insight Global is seeking a Sr. QA Specialist for a Fortune 250 company to join their team in Elkhorn, Nebraska. The site is currently undergoing a major expansion with new and expanded SCADA, building management, and equipment level control systems. This person will be responsible for providing quality and compliance oversight for the transfer of 22 antigens from one building to a new building. Ideally the candidate will have worked in a FDA/USDA regulated environment in the past, has quality assurance experience, and knowledge of GMP requirements. They would need to have experience assisting in assessments for both manufacturing and testing activities along with updating the outline, blueprint, and legend. The company is in the process of expansion plans and the team is in need of someone who will be providing support for internal teams that have had an increase in project demand. The ideal candidate will be a team player, is eager to learn more about the industry, and expand their knowledge on quality assurance, process analysis & support.

    Compensation:

    $40/hr to $50/hr.

    Exact compensation may vary based on several factors, including skills, experience, and education.

    Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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