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    Senior Quality Engineer - Los Angeles, United States - Mantell Associates

    Mantell Associates
    Mantell Associates Los Angeles, United States

    2 weeks ago

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    Description


    Mantell Associates is currently partnered with a fully integrated CDMO with global sites, who are seeking a Senior Quality Engineer to provide experienced QA support from product development through cGMP clinical and commercial production.

    Senior Quality Engineer - Responsibilities

    :

    Oversees F&E activities in real time (QAOTF) to ensure compliance with internal procedures and global regulatory requirements are met
    Provide equipment, system, and facility validation /qualification guidance and ongoing support for established / validated processes
    Leading cross-functional activities, in providing approach, methodology and deliverables
    Partnering with project teams to provide solutions for validation of systems following a risk-based approach
    Assist in developing and reviewing validation documents with functional teams, ensuring the documentation meets compliance requirements, quality standards, and current industry expectations
    Track and report status and progress of qualification activities or projects to direct manager and / or management review
    Identifies root causes of problems in the production process or as a result of investigations; recommends and/or implements corrective measures
    QA review and approver or risk assessments
    Quality point of contact for shutdown activities
    Provide Quality oversight in change control activities to ensure technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state
    Perform investigations and implement corrective actions related to CAPAs and deviations
    Representing Quality Engineering in an emerging industry
    Regular and reliable attendance on a full time basis [or in accordance with posted schedule
    Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices
    Embodies cultural values and aligns daily actions with department goals and company culture

    Senior Quality Engineer - Requirements:

    Bachelor's degree required (ChE, EE, IE, ME, CS, or similar) and 5+ years applicable cGMP experience in regulated industry
    Exceptions may be granted for equivalent work experience or graduate degree
    Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity
    Knowledge of Fill Finish and Biologics production environments preferred
    Familiarity working with electronic batch records
    Detail oriented and strong interpersonal and verbal communication skills

    Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at

    #J-18808-Ljbffr
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