Document Control Specialist at Eisai in Exton, Pennsylvania

Job Description:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

Job Summary

This position is responsible for the administration of the Document Control Program to support operation of the Biologics Manufacturing Facility at Exton, PA in adherence with cGMPs, EMEA, ICH and JP regulations. Document Control Program includes routine interface with all level of site personnel, Electronic Document Management System (EDMS), Learning Management System (LMS), and Laboratory Information Management System (LIMS) to process and track requests, as well as issue and archive executable and procedural controlled documents.

Essential Functions

The Document Control Specialist will be responsible for the administration of the Document Control Program and electronic Document Management System (VEEVA) to support operation of the Biologics Manufacturing Facility at Exton, PA in adherence with cGMPs, EMEA, ICH and JP regulations.

• Process and track all GMP Document requests, including Batch Manufacturing Records.




• Issue and archive batch records, logbooks, controlled forms, and other executable documents; including scanning upon completion.




• Maintain the security and traceability of controlled electronic and hardcopy documents




• Routine interface with EDMS, LIMS, LMS, TrackWise, and CMMS for document control coordination purposes




• Manage document control work volume to achieve and maintain Commercial readiness




• Ensure document control business continuity.




• Support document migration in Veeva implementation Project




• Document creation, revision, review, approval of documents




• Routine interface with all level of site personnel.




• Procedural document generation, interpretation, and adherence are requirements for this position.




• Perform editorial final format review and proofreading functions to ensure the accurate creation and revision of documentation.




• Participate in document migration from a manual document control system to an EDMS.

Requirements

The Document Control Specialist will be required to have the following knowledge, skills, and abilities:

• Timely processing of all customer requests




• Ability to process documents according to the workflow steps.




• Strong customer service focus with ability to build effective relationships




• Ability to interact with people at all levels of the organization




• Ability to work independently and prioritize assignments




• High level of attention to detail is required




• Strong work ethics and a commitment to high quality work




• Effective written and verbal communication and organizational skills




• Advanced skills in Microsoft Word, Excel, SharePoint, Adobe Acrobat




• Previous experience with TrackWise, CMMS, EDMS, LMS, LIMS, SAP is desirable

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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