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    Quality Control Manager - New York, United States - Filltech

    Filltech
    Filltech New York, United States

    3 weeks ago

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    Description

    POSITION :
    Quality Control Manager

    REQUIREMENTS:
    Combination of advanced degree (such as Bachelors or Masters in science) and 3+ years of experience in high volume manufacturing preferred
    Previous experience within a cGMP compliant facility and Quality Assurance/Quality Control preferred
    Ability to perform physical sampling/testing and instrumental chemical analysis in the chemical laboratory (e.g., chromatography, infra-red spectroscopy, titrations, etc.)
    Excellent analytical and problem-solving skills
    Excellent time management and organizational skills
    Ability to work effectively in a fast-paced, rapidly changing environment
    Excellent people skills, with demonstrated ability to communicate effectively across functional groups
    Proficiency with Microsoft (MS) Office

    JOB DESCRIPTION:
    The Quality Control Manager will perform their role as follows:
    Reports to Quality and Regulatory Affairs Manager
    Assist with the developing, implementing, maintaining and adherence of the Quality System
    Manage departmental activities in accordance with available budget, resources and personnel
    Interviews, hires and trains department staff

    Manage the Quality Control internal laboratory activities and analytical team – which includes the analysis of raw materials, batches, and finished products.

    Assist with all Regulatory and Customer inspections
    Assist with reports and other documentation as required by Regulatory agencies and Customers, including post-marketing surveillance activities such as Product Recalls
    Assist with Vendor Qualification program by reviewing and testing raw materials.
    Review and approve internal laboratory testing and external contract testing laboratory reports for materials and finished products. Manage the selection and qualification of external laboratories for required testing,
    Review and approve master batch records prior to quality release.
    Review and approve Certificates of Analysis
    Prepare, review and approve IQ/OQ/PQ Protocols/Reports for production and laboratory equipment / instruments
    Prepare, review and approve new and revised Standard Operating Procedures (SOPs) and Forms
    Prepare, review and approve investigations and corrective/preventative actions (CAPA)
    Manage the facility's Purified Water System, working with a third-party for maintenance and water testing.
    Oversees and maintains the Pest Control program for site.
    Manage the facility's Environmental Monitoring Program
    Perform additional job-related duties, as required
    Delegate responsibilities to assigned designees, as necessary
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