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    Sterility Assurance Manager - New York, United States - BioTalent

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    Sterility Assurance Manager – North Carolina – Competitive Package

    I am representing an established, global health care provider who is on the search for a Sterility Assurance Manager.

    You will be responsible for ensuring site policies are in place to meet requirements for contamination control of cleanrooms, manufacturing processes, and products.


    This role will offer you:
    A genuine opportunity to make a difference, being exposed to a variety of development projects which have the potential to save lives
    A lot of mobility and autonomy in the role, while working with a strong leadership team
    To act as the Sterility Assurance SME for a state of the art manufacturing facility
    Competitive salary, stock purchase program, Tuition reimbursement, PTO, 401k match, Medical/Dental/Vision coverage

    You will be responsible for:
    Developing and driving continuous improvement initiatives within the Sterility Assurance program
    Acting as a sterility assurance SME during audits and inspections
    Overseeing and managing microbiology laboratory activities - environmental monitoring, microbiology testing, microbial identification
    Writing and reviewing environmental cleaning protocols to support cleaning practices and authoring SOPs to support continuous improvement and CAPAs
    Responsible for the training program for cleanroom and contamination control practices


    Desirable experience and qualifications:
    Significant experience with microbiology within an aseptic or sterile manufacturing facility
    BS degree in Science, concentration in Biology or Microbiology, preferably
    Significant GMP experience and strong understanding of current regulations for sterility assurance
    Strong leadership/supervisory experience within a similar environment
    Experience with regulatory inspections and audits


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