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    Associate II, Quality Control, Raw Materials - Norwood, United States - Randstad USA

    Randstad USA
    Randstad USA Norwood, United States

    3 weeks ago

    Randstad USA background
    Pharmaceutical / Bio-tech
    Description

    Title: Associate II, Quality Control Raw Materials

    Reports to: Associate Director, Quality Control

    Function/Department: Quality Control

    Regulatory Relevance: GxP and GMP

    Location: Norwood, MA

    The Role:

    Reporting to the Associate Director of Quality Control, is seeking a Quality Control Raw

    Materials Associate II based at their Norwood, MA site. The individual in this role will perform QC

    Raw Material activities in support of GMP Manufacturing and further support special projects as

    assigned. This position will be 1 st shift working Monday through Friday.

    Key Responsibilities:


    • Requesting, sampling, and peer review of raw materials.


    • Sample coordination including cross functional collaboration with internal and external labs.


    • Train and perform testing for methods including HPLC, Bioanalyzer, osmolality, pH, conductivity,

    TruScan RM spectroscopy, appearance, and dimensional verification.


    • Inspect raw material retain samples.


    • LIMS (LabVantage) sample logging and result entry.


    • Raw material and consumable component inspection and release.


    • Clean room gowning and aseptic techniques.


    • Managing/stocking of QC lab supplies and routine lab cleaning.


    • Complete and maintain cGMP documentation for work performed.


    • Participate in supporting quality systems records such as deviations, change controls, CAPAs and

    investigations


    • Establish and maintain a safe laboratory working environment.


    • Foster a positive and inclusive work culture that promotes collaboration, innovation, and

    continuous improvement.


    • Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with

    regulatory and internal requirements.


    • Execute tasks precisely as defined in internal guiding documents including but not limited to

    standard operating procedures (SOPs) and work instructions.


    • Follow Good Documentation Practices and Data Integrity requirements to ensure data,

    documentation, and records are completed and maintained for use by the business and

    available to support audits or inspections.


    • Complete training in assigned required learning plan according to the defined timing and the

    prescribed requalification cadence.

    Required Background:


    • Education: Bachelor's degree in a relevant scientific discipline.


    • Experience: 1-2 Years with BS or 4+ experience in GMP QC laboratory setting.

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