Document Facilitator
1 Squibb Drive New Brunswick, NJ 08901 US
Job Description
*Depending on experience
Position Summary:
This position is in the GxP Sample and Data Management Group within the product development division.
The team is seeking a hardworking, results-focused Document Facilitator who will assist in the formatting, facilitation, and document approval process through GMP documentation systems.
The position will work with analytical scientists in the delivery of complete and thorough analytical work packages to support clinical Biologic drug substances and drug products.
This position will report directly to a Senior Manager within the Sample and Data Management (SDM) Group of the Analytical Strategy & Operations (ASO)-GxP Biologics department.
DUTIES & RESPONSIBILITIES:
Essential Duties and Responsibilities include, but are not limited to, the following:
• Edit and format GMP documents including Specifications, SOPs, and Technical Documents.
• Facilitate the routing of technical documents through required workflows.
• Review documents for grammatical errors and formatting.
• Work with several technical teams and collaborators at Biologics manufacturing sites, including Analytical testing, Process Development, and Materials Sciences. Additionally, there will be significant collaborations with site specific and global QA teams to ensure technical documents are approved in a timely manner.
• Support clinical work through data management of release and stability samples within the PDLIMS system. Facilitate needed corrections in PD LIMS and work with analysts on solving issues.
• Create PDLIMS release specification templates. Work with subject matter experts to ensure specifications align with approved documents and are completed on time to support manufacturing.
• Cross-training in other areas of ASO-GxP Biologics as needed.
Professional Qualifications:
• A.S. or B.S. or equivalent with a degree in Science, Communications, or English preferred.
• Experience in MS Office applications, in particular MS Word, PowerPoint, and Excel is required.
• Familiarity with electronic documentation systems (e.g., Qumas, Infinity/Veeva) for routing development and investigational documentation is a plus.
• Experience in a GMP work environment is strongly preferred
• Experience with the use of scientific reporting applications and ELN software, e.g., VelQuest, Symyx and LIMS preferred.
• The candidate must be able to deliver when working under assigned timelines and demonstrate good communication skills, particularly in documentation of data. Skill in communicating/escalating critical issues to appropriate team leaders and functional area management is necessary.
• Understanding of cGMP and EHS requirements is essential, as is the ability to comply with all applicable SOPs, internal department requirements, and external regulations.
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