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Quality Assurance Specialist (Pharma)

R&D Partners

Quality Assurance Specialist (Pharma)

Frederick, MD
Full Time
Paid
  • Responsibilities

    Job Description

    Cutting edge pharmaceutical company is in search of QA Specialist.

    •    Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.

    •    Coordinate and facilitate Quality Assurance related production and production related activities, including on-the-floor Quality support to manufacturing, QC and Warehouse.

    •    Provides clerical and administrative support related to documentation processes and systems.

    •    Scans, verifies, and archives documentation and records as needed

    •    Ensure that tests are performed, and products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines.

    REQUIREMENTS:

    •    Bachelor's degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 1-3 years of experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.

    •    Knowledge of GMP, SOPs and quality systems.

    •    Ability to effectively negotiate and build collaboration amongst individuals. Strong interpersonal, verbal and written communication skills.

    •    Experience with change control practices and strategies.

    •    General knowledge of aseptic manufacturing processes.

    Company Description

    The hiring company is an American biotechnology company that develop and commercializes innovative biopharmaceuticals for serious diseases and medical conditions.