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    Director of Quality - New York, United States - Staffing

    Staffing
    Staffing New York, United States

    3 weeks ago

    Default job background
    Human Resources
    Description

    RELOCATION ASSISTANCE OFFERED
    Job Outline
    The Quality Director is a highly critical and responsible position that oversees all Quality activities within a manufacturing company.

    Assigned personnel will be required to maintain a high level of customer service while providing continuous quality improvements to ensure ongoing success on current and future production lines.

    The Quality Director will manage the members of the QA team and will ensure all staff receives adequate training on quality procedures, protocols, and required documentation.

    Responsibilities

    Maintain Quality documentation and standards

    Establish quality and regulatory standards by studying product

    Review of cGMP documents to ensure company processes are compliant with applicable cGMP standards and regulations

    • Develop and adhere to specification for raw materials, components, in-process checks, and finished products while working with cross-functional teams, customers, and external laboratories
    • Verify inspections and testing of raw materials (Certificate of Analysis) to ensure vendor compliance with specifications
    Implement production line inspection standards by studying manufacturing methods

    Prepare quality reports by collecting, analyzing, and summarizing information and trends

    Train staff on quality procedures, protocols, and documentation

    Report on the performance of the quality system to executive management

    Act as a liaison to internal/external parties relating to the quality system

    Review batch documentation and disposition products to ensure quality

    Lead fast-paced, high-volume QA division to deliver optimal quality, training, and experience

    Drive continuous improvement of core processes to ensure manufacturing quality is maintained while efficiency is optimized

    Ensure annual outside auditing requirements are met for our current certifications (NSF, USDA
    Organic, Kosher, cGMP, etc.) and future certifications

    Coordinate incident investigations and material reviews with cross-functional teams, executive team, customers, and suppliers

    Manage and train less experienced members of the QA team on quality procedures, protocols, and documentation

    Write and maintain Standard Operating Procedures (SOPs) for the manufacturing process and supporting controlled documents for warehousing, manufacturing, analyzing, and release processes

    • Maintain sampling program for retention samples and finished products
    • Develop and manage change control process working with cross-functional team members
    • Manage supplier and contract service qualification programs
    Other duties as assigned
    Qualifications

    Bachelor's Degree or equivalent experience

    Experience with QC measuring and testing equipment

    In depth understanding of quality control procedures and relevant legal standards

    Experience with MS Word, Excel, Project Management and Analytics software

    Must have Dietary Supplement GMP training (21 CFR 111) and working experience with the standards and requirements

    • 4 or more years' experience as QA director or similar assignment with in the dietary supplement field
    Extensive knowledge in a broad range of Dietary Supplements CGMP activities and Quality Systems

    • Has current an FDA approved course for Preventive Controls Qualified Individual (PCQI) or is willing to train
    Internal and external auditing training/certification

    Working knowledge of NSF, USDA Organic, Kosher, 21 CFR 111 cGMP requirements and auditing
    Requirements
    This position is active and requires sitting, standing, walking, bending, kneeling, stooping, and crouching all day.

    The assigned personnel must frequently lift and/or move up to 15 pounds and occasionally lift or move up to 25 pounds.

    While performing to assigned job, the employee is required to speak, see, and hear clearly.

    Job Type:
    Full-time


    Pay:
    From $100,000.00 per year


    Benefits:
    401(k)
    401(k) matching
    Dental insurance
    Flexible schedule
    Health insurance
    Life insurance
    Paid time off
    Retirement plan
    Vision insurance
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