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14 days old

Document Specialist, Warren, NJ

Kelly Services
Warren, NJ 07059
Celgene Pharmaceutical- QA Document Specialist Warren, NJ 07059



Requirement: 9427





Core Skills: Deviation/CAPA systems/ComplianceWire/Veeva system; GMP and GDP





Responsibilities will include, but are not limited to the following:



Issuance and reconciliation of Laboratory Forms



Creation, modification, issuance, reconciliation of logbooks as well as and updates to templates



Revise documents as new issues arise and maintain revision control



Document control & review process of all documents in both the Veeva system and paper documents. Will work directly with various departments to ensure documents are accurate.



Support Periodic Review of Controlled Documents process as well as provide reports and metrics. Document Center management, reconciliation and cataloging of physical records



Document Center escort for requestors without card key access in order to review physical records. 80% desk review/computer work





Additional responsibilities:



Participate in project team meetings and assist the teams in resolving issues related to document preparation and management.



Work with Document Specialist and local functional areas to initiate and maintain electronic repository, and contribute to the authoring, review, and approval process for electronic documents. Attend QA Department Group Meetings to become informed in upcoming needs.



Implement the strategy for document preparation and review that meet or exceed company standards and the document review processes.



Provide customer support and training for users in the electronic document system.



Provide additional support in processing CELSERVICE system requests.





Skills/Knowledge Required:



Excellent written and communication skills



QA background and familiar with basic GMPs and Good Documentation Practices



Applicant would spend most of their time in the computer-based systems related to Document Control. Develop and provide system reports and metrics on a weekly basis.



Management of physical GMP documents



Knowledge of Veeva, ComplianceWire and Deviation/CAPA systems would be a plus.








**Why Kelly** **** **?**



Kelly Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-05-11 Expires: 2020-06-11

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Document Specialist, Warren, NJ

Kelly Services
Warren, NJ 07059

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