WuXi AppTec

  • Quality Assurance Specialist

    Job Locations US-PA-Philadelphia
    Job ID
    2018-3744
  • Overview

    Reviews manufacturing and/or testing batch 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.

    Responsibilities

    • Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (e.g.: 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 CoAs, 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 Non-conforming Events (NCE), Deviations, Laboratory Investigation Reports (LIR), and CAPA investigations.
    • Write and revise SOPs as necessary.
    • Perform timely review of complex study files, such as: Assay Validations, Qualifications, and Viral Clearance.
    • Leads and participates in Internal/External/Client Audits and Audit response writing.
    • Lead/Participate in quality and process improvement initiatives, and project teams.
    • Evaluate and perform trend analysis and report results for quality metrics. Make recommendations and drive implementation based upon findings.
    • Participates in operations and client meetings as QA representative.
    • Assists with managing the daily work flow of Quality Associates and Quality Specialists, providing additional guidance as needed on quality decisions.
    • Assists Management in the training of new hires.

    Qualifications

    Experience / Education:

    • 6+ years of relevant experience or equivalent
    • 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 judgment 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

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