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    CSV/Quality Analyst - New Jersey, United States - CMK Select

    CMK Select
    CMK Select New Jersey, United States

    6 days ago

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    Description

    CMK Select, a leading consulting firm dedicated exclusively to the Pharmaceutical / Life Science industry, is seeking a talented and experienced individual to join our team as a Computer System Validation/Quality Assurance Specialist

    Hybrid Role: Rahway, NJ 3 days onsite

    Job Description

    • Provide for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality organization.
    • Act as the Quality Unit representative for information technology products such as infrastructure, business applications, shop floor automation systems and standalone, laboratory instrument system.
    • Promote and build Quality Management System elements into the end-to-end computer system validation process, thereby promoting permanent inspection readiness.
    • Provide independent Quality Assurance oversight for the implementation of new computerized systems, change control involved with existing computerized systems as well as the retirement of computerized systems in the Clinical Supply domain.
    • Develop and maintain an overall computer system validation posture and program for a defined functional area(s) (single point of contact) within Clinical Supply, including support for System Development Life Cycle deliverables and testing.
    • Act as a liaison with respect to the Quality Management System and Compliance pillars of Global Development Quality for the purposes of investigations, corrective action/preventive action, procedural controls, auditing and Quality Risk Management.

    Qualification:

    • 5-8 years in Pharmaceutical/Biotechnology industry; experience working in a regulated (e.g. GxP) environment.
    • Knowledge of FDA regulations, particularly 21 CFR Part 11, Part 58, Part 210, and Part 21
    • Demonstrated expertise in SLC methodologies, including V-model, waterfall, agile, and spiral, with a strong understanding of their application to CSV activities.
    • Proficiency in change management principles and practices, with experience implementing change control processes within validated environment.
    • Experience in providing oversight for adherence to enterprise SLC and procedure.
    • Overall proficiency in dealing with and understanding laboratory facilities and equipment.
    • Proficiency in both written and verbal communication, complemented by a comprehensive understanding of Good Documentation Practice.
    • B.S. and/or M.S. degree in an appropriate Life Science, Computer Science, Information Technology or Engineering discipline

    Nice to Have Skill

    • Experience with calibration and qualification
    • Experience with configuration management
    • Knowledge of published regulatory agency data integrity guidance
    • Moderate level of experience with electronic tools such as software providing document management and testing capabilities
    • Some level of experience with IT Infrastructure Language and service management

    CMK Select offers Medical/Dental/Vision/LTD/STD Benefits Coverage, Paid Holidays, Paid Time Off, 401k and discretionary annual cost of living increases.

    This is an Associate level position at CMK Select, with an initial compensation between $100,00.00 to $110, Salary will be commensurate with experience.

    For immediate consideration, please contact Monika | e

    CMK Select is an Equal Opportunity Employer

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