- Expiry Date: 04 June 2022
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.
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.