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Blanchester

    Quality Systems Associate - Princeton, United States - ResourceMFG

    ResourceMFG
    ResourceMFG Princeton, United States

    1 week ago

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    Description

    summary Position Description:

    The QS Associate will supervise the activities with development, application, training, and maintenance of quality standards for industrial processes at Vytalogy Wellness.

    The QS Associate will also be assisting with ensuring that all products meet the established quality standard according to "The Code of Federal regulations Title 21- Food and Drugs".

    This position supervises the Quality System Training, Material Reviews and Disposition (MRD/MRB) as well as assists Consumer Affairs with the investigation and approval of Consumer Complaints.

    This position provides support to the QA/QC, R&D, Production/Procurement departments, and Technical Support/Consumer Affairs group.


    Responsibilities:
    1. Facilitates the change control process across Vytalogy sites. 2. Coordinates with the Consumer Affairs team on Non-serious Adverse Events and follows up on the non
    • SAERs forwarded by Consumer Affairs to QS.
    3.

    Facilitates all the complaints process including complaint investigations, the supplier quality program as well as the Material Review Board process.

    4. Logging, routing, follow-up, implementation, and closure of all change controls. 5. Assist with the CM incoming quality inspections review and final lot release. 6.

    Ensures the reviews and coordination of vendor raw material CofA's, product specifications, SDS, and other product-related information from vendors, as instructed by supervisor/manager.

    7. Assist with the Document Controls DCR/SOPs/Training Documentation. 8. Assist with Deviations/ CAPA and non-conformance tracking and follow-ups. 9.

    Assist with the creation finished products, bulk products and raw material specifications sheets in accordance to " The Code of Federal regulations Title 21- Food and Drugs 111.70" 10.

    Assists the department with any tasks related to cGMP implementation and maintenance. 11. Coordinates with the Consumer Affairs on the investigation of on-serious Adverse Event Reports, and other customer complaints. 12. required-skills: BA/BS in Chemistry or related discipline with 2 to 4 years' experienceinaQA/QCenvironment1years' experienceina QA/QCenvironment Knowledge/ExperienceincGMPandotherpertinentregulations Experiencewithregulatoryinspectionswouldbeadvantageous. cGMP and regulatory knowledge of relevant FDA and globalstabilityguidelines. Excellent analytical and problem-solving skills and written andverbalcommunication. required-experience: 2+ years
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