WuXi AppTec

  • Quality Assurance Compliance Specialist II

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4350
  • Overview

    Primary Quality Assurance Representative for review of GLP Final Reports, GMP Certificates of Analysis (CoA’s), Assay Validations, deviations, and CAPAs.  Reviews laboratory testing data or manufacturing 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

    • Focused QA Representative on review/approval of Non-Conforming Events (NCEs), Deviations, Laboratory Investigations (OOS), and CAPA’s; will coach/mentor Laboratory personnel in development of technical writing skills.
    • Ensures site adherence to Quality Systems.
    • Perform timely review of complex study files, such as: Assay Validations, Process Validations, and Viral Clearance.
    • 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 and manufacturing suites.  Interact frequently with operations/facility staff to provide quality perspective on routine operations and support systems.  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.
    • 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.
    • Performs Laboratory and Manufacturing Suite inspections.
    • Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections.
    • 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.
    • 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

     

    Qualifications

    Experience / Education   

    • 7 or more years of experience
    • Bachelors’ degree in a Science related field or equivalent experience

     

    Knowledge / Skills / Abilities:

    • Scientific, Laboratory, and/or Production experience required. Extensive experience is highly preferable.
    • Knowledge of FDA GLP/ cGMP requirements, FDA PTC guidelines required.
    • Knowledge of EU cGMPs highly desirable.
    • Knowledge of FDA PTC & MHRA Out-of-Specification guidance documents required.
    • Knowledge of Root Cause analysis techniques required.
    • Extensive experience writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA’s preferable.
    • 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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