WuXi AppTec

  • Associate Quality Assurance Specialist

    Job Locations US-MN-St. Paul
    Job ID
    2018-4498
  • Overview

    The Associate Quality Specialist is responsible for ensuring GLP studies, GMP testing, and GMP manufacturing activities are executed in accordance with the appropriate regulatory bodies and internal procedures. 

    Responsibilities

    • Ensures compliance to Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP).
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
    • Performs audits (critical phase and manufacturing) and appropriately documents the findings.
    • Reviews final reports (GLP), batch records (cGMP), Certificates of Analysis (GMP), and/or other necessary documentation, as appropriate to the defined Quality Role within the applicable regulation(s).
    • Assists with internal audits, as requested.
    • Performs QC review activities, where applicable.
    • Assists in identifying and initiating QA CAPA activities (deviations, lab investigations, OOS).
    • Ability to work in a team environment and independently.
    • Contributes to the achievement of departmental goals.
    • May be required to work weekends.
    • May be required to work Holidays.
    • May be required to assist in other departments.
    • Other duties as assigned.

    Qualifications

    Experience / Education

    • Minimum 0 years of experience
    • Bachelor’s Degree or equivalent
    • Scientific background preferred

    Knowledge / Skills / Abilities:

    • Proficient Oral & Written communication skills
    • Need to be able to read, write and understand English
    • Proficient in Microsoft (Excel, Word, Outlook)

    Physical Requirements:

    • Must be able to work in a Lab setting with exposure to animals/biohazards/chemical (list chemicals)
    • Must be able to wear appropriate PPE
    • Must be able to work in environment with minimal noise levels
    • Ability to stand for long periods of time
    • Clarity of vision
    • Ability to identify and distinguish colors
    • Must be able to perform activities with repetitive motions
    • Ability to lift 25 lbs routinely/often/occasionally
    • Ability to crouch, bend, twist and reach
    • Ability to push/pull 25 lbs routinely/often occasionally
    • Ability to work in variable temperatures high to freezing
    • Inside working conditions

                                                                                                       

    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, or protected veteran status and will not be discriminated against on the basis of disability

     

    This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Need help finding the right job?

    We can recommend jobs specifically for you! 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, or protected veteran status and will not be discriminated against on the basis of disability Click here to get started.