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    QA Lead Technical Operations, Projects - Devens, United States - TechDigital Corporation

    TechDigital Corporation
    TechDigital Corporation Devens, United States

    1 week ago

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    Description
    QA Lead Technical Operations, Projects

    Onsite, Devens location

    Work Schedule:
    Mon - Fri, First shift (8:30AM - 5PM)


    Job Description/ Responsibilities:
    " Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and

    approval of Investigations and Corrective Actions.

    " Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations

    " Reviews and approves Quality, Quality Control, Validation and Automation related documents

    " Review and approves Standard Operating Procedures (SOPs).

    " Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and

    summary reports.

    " Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet

    external regulatory and internal WWQC guidelines and requirements.

    " Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk

    assessments and Validation.

    " Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working

    environment

    " Able to interpret complicated data and make sound decisions, Independently

    This position will regularly interact with:

    Reporting Manager

    Sometimes will interact with departments listed below:

    Quality Control

    Manufacturing Operations

    Manufacturing Engineering

    Manufacturing Science and Technology (MS&T)

    Validation

    Site Engineering

    Digital Plant


    Education, Experience, and Qualifications:
    " Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering,

    biochemistry, or related discipline, or its equivalent is preferred.

    " Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product

    quality. Preferred Active member of ASQ or ISPE.

    " Prior experience of QC equipment Qualification and some project management experience

    " Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is

    highly desirable.

    " Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.

    " Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic

    or paper based batch records desirable.

    " Excellent Technical writing and oral communication skills are required.

    " Background in problem solving

    " Knowledge of Data integrity principles

    " Proven attention to details

    " Comfortable working in an FDA regulated environment.

    Contractor must be able to come onsite Monday through Friday - 1st shift
    #J-18808-Ljbffr


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