USA

QA Documentation Specialist II

locationAlachua - Florida (FL), 32615

atOlogy Bioservices

Estimated salary $32,697 - $72,718 a year

Job Description:

Summary: The QA Documentation Specialist is responsible for providing clerical and administrative support related to the generation and maintenance of documentation. The QA Documentation Specialist reports to the QA Documentation and Trending Supervisor.

Essential Responsibilities:

  • Scans and archives a high volume of documents in an organized manner.
  • Certifies scanned documents to ensure a true and accurate scan of original documentation is obtained.
  • Assists employees with document preparation including formatting and pagination.
  • Converts the format of documents as needed to match the appropriate document template format.
  • Assists with the progression of documents through the Document Control Lifecycle in MasterControl.
  • Label generation and reconciliation.
  • Provides controlled prints/copies of documents needed for execution as required.
  • Updates logs, databases and catalogues of regulatory compliance information
  • Maintains master document files.
  • Maintains tasks in QA Document Tracking/Help Desk system.
  • Provides support for internal and regulatory audits and inspections as required. Provides hardcopy or electronic Document Control files for onsite or virtual audits.
  • Assists Supervisor and other Team Members by monitoring and continuously improving the Document Management System by evaluating supporting documentation to ensure compliance to CGMP, industry standards and other applicable
regulations.
  • Assists with the writing and review of standard operating procedures (SOPs), work instructions, and forms related to the Document and Quality Management System as required.
  • Participates on project teams and provide necessary support to meet required project deadlines.
  • Assists with gathering of data needed for metric reporting as required.
  • As this position requires extensive interaction with employees throughout the organization, the individual must maintain a high level of internal customer service.
    • All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

    Minimum AA/AS degree or minimum 1 years related experience in FDA-regulated industry, preferably in vaccine, biologics or pharmaceutical industry with professional experience including:

    • Possesses strong verbal/written and interpersonal communication skills as a team player and willing to work in an environment where individual initiative, collaboration and accountability are valued.
    • Proficiency in Microsoft Office with ability to input data into other software programs.
    • Experience with Trackwise, NextDocs, MasterControl or other electronic Quality and/or Document Management System is preferred.
    • Highly organized with an excellent attention to detail.

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