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    Quality Assurance Manager - New York, United States - LHH

    LHH
    LHH New York, United States

    3 weeks ago

    LHH background
    Description

    KEY JOB FUNCTIONS
    Develop, edit, review, and approve validation protocols and reports.
    Plan, implement, communicate, and maintain quality programs in compliance with ISO, cGMP, and industry standards.
    Set quality assurance objectives for review and approval by Top Management.
    Manage internal ISO audit process and oversee corrective actions.
    Manage ISO document control process, including review and approval of SOPs.
    Participate in new product development for quality assurance.
    Design and implement an effective CAPA process with the Quality team.
    Establish and maintain supplier approval and audit process with Procurement.
    Manage sterile validation process for manufactured products.
    Understand global regulations affecting product lines and ensure compliance.
    Manage company's change control process.
    Work with Marketing to review and update product technical information.
    Establish targets for quality improvement efforts and track results.
    Design and implement quality training programs.


    DESCRIPTION OF CANDIDATE
    Demonstrate integrity and professionalism.
    Maintain a positive attitude in the face of challenges.
    Maintain a professional demeanor internally and externally.
    Maintain high attention to detail for compliance.
    Ability to work independently and in a team.
    React with urgency to production and customer needs.
    Communicate effectively with all levels of the organization.


    QUALIFICATIONS OF CANDIDATE
    Bachelor's degree or higher in science or engineering.
    Ten years experience in manufacturing, including five + years in quality management.
    Solid understanding of sterility validation and guidelines.
    Strong knowledge of FDA, cGMP, and ISO requirements.
    Excellent written communication skills.
    Ability to prepare and present information effectively.
    Ability to use judgment in problem analysis and decision-making.
    Excellent computer aptitude and knowledge of Microsoft Office and ERP systems.

    DESIRABLE SKILLS / EXPERIENCE
    Textile industry experience.
    Pharmaceutical or medical device industry experience.
    Lean/Six Sigma knowledge and experience.
    Previous experience with ISO 9001, ISO 14001, and ISO 17025 systems.
    Previous experience with LIMS systems.
    Previous experience with EPA or BPR regulations for disinfectant products.


    PHYSICAL REQUIREMENTS
    Use testing equipment and operate computer.
    Stand, walk, sit, reach, lift up to 25 lbs.
    Climb, balance, stoop, crouch, crawl, smell.
    Close, peripheral, and depth perception vision.
    Work in a normal office environment.
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