WuXi AppTec

  • Document Control Quality Associate

    Job Locations US-CA-San Diego
    Job ID
    2018-3602
  • Overview

    Document Control Specialist will be responsible for controlled documents and records at the HD Biosciences San Diego facility. Controlled documents may include SOPs (Standard Operating Procedures), memos, policies, and training records. He/She will also be responsible for document control, deviation and other Non-conformances, CAPA, Equipment/Instrument associated systems, and Supplier Management.

    Responsibilities

    • Support the development, and implementation of Quality Systems
    • Performs QA document control function, including document login, tracking, processing, approval, distributing, and archiving and has overall responsibility for document control processes.
    • Process all Document Control Requests (DCR’s), route and track the document review, approval and distribution.
    • Review document drafts for grammar, spelling and formatting and making corrections as needed for making documents effective for use.
    • Send out documents for periodic review requests to department heads
    • Maintain electronic folders of drafts, edits and approved/effective documents.
    • Maintain hardcopies of documents and update QA binders with current versions
    • Establish employee training matrix for all new employees, ensuring all training is completed and the training records are maintained and filed.
    • Maintains in house training programs including training matrix, training files, and audits of training files.
    • Assist with planning of internal and external audits to ensure compliance with current practices.
    • Help implement Supplier Management and CAPA processes
    • Train, support and advise end users on the Document Management System requirements and workflows.
    • Assist with other company administrative tasks as needed.

    Qualifications

    • Bachelor’s degree in life science or related discipline with 1-3 years document control experience.
    • Must have an understanding of documentation control systems and experience writing SOP’s.
    • Expertise with MS Word, Excel, Office software.
    • Excellent organizational skills and attention to detail.
    • Effective communication (both oral and written) required for interacting with all departments within the company as well as clients and outside agencies.
    • Experience with implementing and managing key Quality Management System processes (e.g., Change Management, Supplier Management, Deviations/CAPA, Management Review)

     

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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