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SR. ASSOCIATE – Amgen Careers West Palm Beach

    Website Amgen

    Position Title: SR. ASSOCIATE

    Company: Amgen

    Location: West Palm Beach, FL, USA

    Job Description:

    If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.

    Responsibilities:

    • Perform all activities in compliance with Amgen safety standards and standard operating procedures.
    • Observe and provide real-time quality oversight and support for manufacturing on the floor.
    • Perform purposeful presence on the floor audits.
    • Perform manual visual inspection AQL audits of vials and syringes.
    • Perform QA reserve sample inspections as part of the annual reserve inspection program and in support of customer complaint investigations
    • Certification of defect panels.
    • Provide quality support for triage and investigation of all classes of deviation events.
    • Review/approve deviations for closure ensuring compliance with appropriate standards.
    • Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities.
    • Provides training and advice to staff in order for them to perform their desired functions.
    • Write, review and approve standard operating procedures in accordance with Amgen policies.
    • Support continuous improvement and operational excellence initiatives
    • Any other tasks/projects assigned as per manager’s request.

    Requirements:

    • Excellent written and verbal communication skills
    • Experience working with dynamic cross-functional teams and proven abilities in decision making
    • Strong organizational skills, including ability to follow assignments through to completion
    • Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
    • Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
    • Operational Excellence experience

    To apply for this job please visit careers.amgen.com.


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