WuXi AppTec

  • Quality Assurance Specialist

    Job Locations US-PA-Philadelphia
    Job ID
  • Overview

    Reviews Laboratory Testing data/records in accordance with current Good Manufacturing Practices (cGMP), and Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies, as applicable.  Monitor processes for adherence to established procedures/regulatory compliance.  Provides guidance for quality related issues and consults with QA Management to resolve complex quality issues in a timely manner.


    NOTE:  We  have several positions available to include Sunday-Thursday and Tuesday-Saturday FIRST SHIFT.


    • Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.).
    • Maintains awareness of activities by routine direct observation of testing laboratories. Interact frequently with laboratory/operations/facility staff to provide quality perspective on routine operations and support system.  Address conditions/practices with appropriate personnel, documents and reports findings to Management.
    • Compiles and reviews raw data / laboratory test results, including Final Reports, and CoA’s, in accordance with cGMP, cGLP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
    • Reviews and approves Deviations.
    • Write and revise SOPs as necessary.
    • Reviews and approves document change requests.
    • Perform QA inspections including, but not limited to GLP studies.
    • Participate in quality and process improvement initiatives, and project teams.
    • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
    • Normally receives minimal instructions on routine work and detailed instructions on new assignments.
    • Works under close supervision from supervisor or senior personnel.
    • Ability to work in a team environment and independently as required
    • Contributes to the overall operations and to the achievement of departmental goals
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
    • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
    • Other duties as assigned
    • May be required to assist in other departments


    Experience / Education

    • 0-5 years of relevant experience
    • Bachelors’ degree in a science related field or equivalent experience


    Knowledge / Skills / Abilities:

    • Knowledge of GLP and cGMP requirements, PTC guidelines and ISO17205 is highly desirable.
    • Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, Outlook, and Access).
    • Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations.
    • Ability to record data accurately and legibly.
    • Ability to use judgement as dictated by the complexity of the situation.
    • Ability to understand and follow verbal or demonstrated instructions.
    • Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
    • Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication.
    • Proficient in Oral & Written communication skills
    • Need to be able to read, write and understand English


    Equal Opportunity Employer Minorities/Women/Veterans/Disabled 


    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.