• Associate Quality Assurance NS

    US Tech Solutions (New Albany, OH)


    Duration: 12 months

     

    Swing shift - 12-hour shifts - Must have flexibility with shifts

     

    10PM - 6:30 AM - may fluctuate over the duration of the contract

    Job Description:

    Ideal Candidate: B.S or relevant experience. GMP background is nice to have.

     

    Nice to have: Veeva, Trackwise, SAP, Maximo, and MES.

     

    Primary responsibilities of this position include inspecting raw materials, components, and labels, in addition to sampling raw materials, labels, and sanitary utilities, and generating/compiling quality data and reports (e.g. lot track/trace, incidents). Will also assist with document review and initiate incidents, as well as coordinate and compile general documents and oversee room clearance inspection.; Skills: ; quality assurance or manufacturing experience in the pharmaceutical or medical device industry

    Key Responsibilities:

    + Provide daily guidance and support to manufacturing staff regarding compliance with Standard Operating Procedures and Work Instructions.

    + Ensure regular presence on the packaging area to provide oversight to GMP operations and quality systems.Act as a first point of contact in case of production staff inquiries (quality related) during operations.

    + Review and approve batch record documentation, assist in sampling and inspections as required and other GMP documentation in support of daily operations.

    + Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.

    + Review and approve minor deviations.

    + Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting Environmental Health and Safety corporate and site goals.

    Qualifications:

    Minimum Requirements:

    + High school/GED + 2 years work experience or Associates degree and 6 months work experience or Bachelor’s degree

    Top 3 must have skills:

    + Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies

    + Experience in and knowledge of GMP/GCP operations or similarly regulated industry

    + Highly effective verbal and written communication skills, strong interpersonal skills

    + Great attention to detail and high degree of accuracy in task execution and GMP documentation

    + Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues.

    + Strong organizational skills, including ability to follow assignments through to completion.

    _Disclaimer:_

    _US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran._