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QC Records Coordinator

Posted 13 days ago

  • Expiry Date: 04 June 2022

Job Description:

  • The QC Records Coordinator will perform inventory, compilation and archival of GMP documents/records related to Quality Control Operations ensuring original records security, facilitate data integrity, ensure easy/timely retrieval of records, and support internal and regulatory inspections.

Education:

  • Associate’s degree or equivalent.

  • Experience Basic Qualifications:

  • Previous experience working in a professional office environment; experience in a cGMP/FDA regulated, medical, financial, or legal environment preferred.

  • Must be able to demonstrate extremely efficient and effective organization skills with extra attention to details.

  • Experience in document and database management is highly desirable.

  • Ability to work effectively at a fast pace with cross-functional departments to finalize time-sensitive deliverables.

  • Able to successfully manage multiple priorities

  • Strong computer skills with MS Office (e.g. Word, Adobe, and Excel), Sharepoint, and with Quality Systems (e.g. Document Management System)

  • Teamwork and the ability to interact well with others are essential.

  • Must be able to self-direct, multi-task, and clearly communicate to the manager of decisions outside of established processes and the ability to build an internal network.

  • Primary responsibilities include:

  • Maintain the QC document archival logs and filing areas.

  • Ensures all paper GMP documents/records are organized, labeled, and stored in the appropriate location in a manner that enables quick and easy retrieval.

  • Manage file inventory and supplies for filing.

  • Establish and maintain practices for document filing and archival.

  • Determine retention periods and schedule document archival.

  • Participates in the development and deployment of site archival programs and initiatives.

  • Support quarterly controlled form reconciliation.

  • Organizes and associates related paper documents/records into a single package or file system. If gaps are identified, work with team members to identify missing elements.

  • Using the existing document tracking tools, ensure accuracy and traceability for all documents stored in the QC GMP document filing areas.

  • Follow and enforce data integrity and chain of custody policies and procedures as set by client and QC.

  • Follow Policies, SOPs and work instructions to support the GMP Records Management process.

  • Support internal and external audits and regulatory inspections. This may require scanning, and document retrieval /organization during regulatory inspections.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.