Specialist, QA Document Control

oxfordbiom•Durham, NC

3d•Onsite

About The Position

At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We’re currently recruiting for an on-site Specialist, QA Document Control to join our Quality team. The responsibilities for this role will cover all aspects of a GMP document lifecycle, and day-to-day documentation support for business operations, playing a key part in advancing our mission and making a real difference.

Requirements

Bachelor’s degree or higher in Data/Information Management or related field
Minimum of 3 years of GMP document control or GMP data management experience
Hands-on experience with creation of GMP documents (e.g. procedures, forms, BRs, etc.)
Comprehensive knowledge of GMP regulations for document and records management
Prior experience with electronic document management system (Veeva)

Responsibilities

Ensures quality activities are carried out according to regulatory and quality requirements.
Support the development, implementation and maintenance of the site documentation management system and ensure alignment with network standards.
Support the day-to-day document control activities for site operations. Some activities may include but not limited to data entry, metric reporting, filing, archiving, logbook lifecycle ownership, controlled copy issuance, periodic review, and batch record production.
Manage the documentation lifecycle which includes documentation formatting without changing content to ensure consistency across documents. Coordinate workflows with task owners to ensure that documents are properly reviewed, issued, approved, periodically reviewed and obsoleted within identified timeframes. Follow up with document owners to ensure that records are completed and documented within established timeframes.
Maintains and facilitates training related to the users of the eDMS, in coordination with QA Training.
Support the development of a site-wide visible business process and expert community to ensure high-quality documents.
Participate in network communities of practice related to eDMS and Veeva.
Support efforts for site Audit readiness and participate as an audit team member.