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    Sr Associate QC - Dublin, Ireland - Amgen

    Amgen
    Amgen Dublin, Ireland

    Found in: beBee S2 IE - 6 days ago

    Amgen background
    Paid Work
    Description

    Job Summary: QC CAS - Sr Associate

    Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing of EU Release, Commercial, Stability, Utilities, raw materials and Validation.

    • Contributes to team by ensuring the quality of the tasks/services provided by self
    • Contributes to the completion of Milestones associated with specific projects or activities within team

    Extended hours and weekend work flexibility may be necessary as required. Please note this is a Fixed Term Contract (FTC) for 12 months.

    .

    Specific Job Duties:

    • Plan and perform analyses with great efficiency and accuracy.
    • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
    • Report, evaluate, back-up/archive, trend and approve analytical data.
    • Troubleshoot, solve problems and communicate with stakeholders.
    • Initiate and/or implement changes in controlled documents.
    • Participate in audits, initiatives and projects that may be departmental or organizational in scope.
    • Review protocols and perform assay validation and equipment qualification/ verifications when required.
    • Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
    • May contribute to regulatory filings.
    • May conduct lab investigations as necessary.
    • Evaluate lab practices for compliance on a continuous basis.
    • Approve lab results.
    • May interact with outside resources.
    • LIMS data coordination of commercial and import testing on site where applicable
    • May represent the department/organization on various teams. May train others.

    Primary Knowledge, Skills, Competencies and Relevant Experience

    Knowledge:

    • Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure & continuous learning
    • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

    Skills:

    • Communication skills (verbal and written) at all levels
    • Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
    • Presentation skills
    • Escalate issues professionally and on a timely basis
    • Decision Making skills
    • Teamwork and Coaching others
    • Negotiation and Influence skills
    • Investigation skills
    • Problem solving skills. Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
    • Ensures compliance within regulatory environment
    • Develops solutions to technical problems of moderate complexity
    • Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
    • Interprets generally defined practices and methods
    • Able to use statistical analysis tools to perform data trending and evaluation
    • Project Management and organizational skills, including ability to follow assignments through to completion

    Competencies:

    • Demonstrated ability to work independently and deliver right first time results
    • Works under minimal direction Work is guided by objectives of the department or assignment
    • Follows procedures
    • Refers to technical standards, principles, theories and precedents as needed
    • May set project timeframes and priorities based on project objectives and ongoing assignments
    • Recognizes and escalates problems
    • Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues
    • Auditing documentation and operation process
    • Demonstrated ability to interact with regulatory agencies

    Relevant experience:

    • Bachelor's degree in a Science related field is required.
    • 4+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,
    • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

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