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 Quality Systems’ Document Control program to support operation of the Biologics Manufacturing Facility at Exton, PA in adherence with cGMPs and regulatory requirements. Document Control includes routine interfacing with all site personnel, the Electronic Document Management System (eDOCS), the Learning Management System (LMS), the Laboratory Information Management System (LIMS), and other systems to process and track requests, as well as issue and archive controlled documents.
Essential Functions
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Process and track all requests for the creation, revision, review, approval, issuance, and archival of GMP controlled documents. This includes procedures, batch records, logbooks, forms, and other executable documents.
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Perform editorial format review and proofreading functions to ensure the accurate creation and revision of the GMP controlled documents.
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Maintain the security and traceability of the electronic and hardcopy GMP controlled documents.
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Routinely interface with electronic systems (e.g., Veeva eDOCS, LIMS, LMS, TrackWise, SAP, etc.) for document control purposes.
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Manage the document archive and offsite storage, including retrieval of documents for site personnel, auditors, and regulatory inspectors.
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Manage document control work volume to achieve and maintain Commercial Manufacturing readiness and business continuity.
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Routinely interface with all site personnel.
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Interpret and adhere to document control policies, procedures, and ways of working; recommend process improvements to increase efficiencies.
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Participate in document control projects and migration activities.
Requirements
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Associates degree or equivalent experience required; Bachelor’s degree in a technical discipline preferred.
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3+ years of document control/management experience (i.e., GMP, GDP, Quality) in the Pharmaceutical industry required; 5+ years preferred.
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Excellent written and verbal communication skills.
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Ability to interact with people at all levels of the organization.
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Strong customer service focus with the ability to build effective relationships and teams.
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Excellent organization skills with the ability to work independently, prioritize assignments, and process document control requests in a timely manner.
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Ability to process documents according to procedural and electronic workflow steps.
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Strong attention to detail, work ethic, and commitment to high quality work.
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Advanced skills in Microsoft Word, Excel, SharePoint, and Adobe Acrobat.
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Experience with electronic document management and workflow systems. Experience with TrackWise, Veeva eDOCS, LMS, LIMS, and SAP is preferred.
#LI-SC1
Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.
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.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
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