• Quality Systems Specialist

    System One (Exton, PA)


    Job Title: Quality Systems Specialist

     

    Type: Contract

    Responsibilities

    + Perform core regional quality systems activities as assigned (e.g., revising procedures; assisting in inspection readiness) following defined procedures.

    + Develop, improve, and revise regional quality system SOPs.

    + Conduct ongoing analysis and reporting of key quality and risk metrics and required actions.

    + Monitor and identify gaps within quality systems area and escalate for appropriate action.

    + Support project management for programs/ projects within quality systems area, and communicate with cross-functional teams within site/ area to drive quality outcomes.

    Requirements

    + Bachelor’s degree, preferably in chemistry, biochemistry, or equivalent technical discipline with 3+ years of experience relevant to role (e.g. auditing and regulatory inspections; learning management systems/ training operations; document control processes; electronic quality systems).

    + Experience in compliance with cGMPs and relevant health authority and Eisai regional guidelines.

    + Experience in execution of quality processes within own quality systems area (e.g., SOP and protocol writing, metrics monitoring), and assisting in resolution of issues .

    + Proven performance in earlier role.

     

    Benefits

     

    System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

     

    Ref: #558-Scientific

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.