Documentation Manager jobs in Raleigh, NC

Documentation Manager manages the production of functional, configuration, and user interface documentation for computer software and hardware products. Develops and deploys standardized documentation methods and tools to efficiently produce high-quality content. Being a Documentation Manager establishes processes for effective document control. Plans and directs documentation projects and timelines. Additionally, Documentation Manager may act as final approver or editor for projects. Requires a bachelor's degree or equivalent. Typically reports to a director. The Documentation Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Documentation Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Manager, Documentation Management
  • Fujifilm
  • Holly Springs, NC OTHER
  • Overview

    Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

    The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

     

    Join us

     

    We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

     

    The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

    Internal Job Description

    About This Role

     

    The Manager, Documentation Management will be responsible for creating and leading the Manufacturing Support Documentation team and their associated activities to ensure compliant and reliable production.

     

    What You’ll Do

     

    During Project Phase:

    • Provide oversight and lead operational readiness projects, including but not limited to: leading the creation of manufacturing documentation business processes, and transferring any applicable business processes from an existing large scale facility, to ensure GMP operational readiness. 
    • Lead, manage and build the support documentation team

    In Operations:

    • Manage, lead, and develop direct reports from the support manufacturing team while overseeing, organizing, and coordinating the workload of the manufacturing documentation team
    • Provide oversight on the coordination of non-batch activities and collaborate cross functionally, including but not limited to: 
      • Batch documentation and associated automation recipe
      • Document creation and project management of manufacturing changeover
      • Preventive maintenance plans (PMs)
      • Column packing documentation and project management
    • Lead the creation and lifecycle management of manufacturing standard operating procedures (SOPs) and work instructions (WIs)
    • Collaborate with Manufacturing, Process Science, Engineering, and other functional groups to transfer in new programs into the facility, including maintaining alignment with other large scale documentation teams
    • Act as a functional manufacturing documentation lead for regulatory inspections and audits
    • Perform other duties as assigned.

    Who You Are

     

    You have the ability to collaborate with manufacturing and other functional areas. You demonstrate strong organizational skills in addition to project management capabilities. You actively champion continuous improvement practices and ideas. You have an advanced understanding of good manufacturing practices, inspection requirements, safety and manufacturing operations. You have the ability to coach, lead and develop individual contributors. You have experience with regulatory inspections, investigations and change management.

     

    Basic Requirements

    • High School Diploma or GED with 10 years of related experience OR
    • Bachelor’s Degree with 6 years of related experience
    • Prior experience managing, leading and developing people

    Preferred Requirements

    • Bachelor’s degree (BA/BS) or master’s degree with an emphasis in life science or engineering with 6-10 years of experience in pharmaceutical/biological manufacturing operations
    • Previous experience leading others in a pharmaceutical/biological manufacturing facility
    • Experience working in a changing, project driven organization
    • Previous experience directly supporting manufacturing

    FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

     

    To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

  • 15 Days Ago

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Senior Documentation Program Manager
  • Red Hat Software
  • Raleigh, NC OTHER
  • About the job Red Hat Customer Content Services is looking for an organized and energetic individual to drive execution of a new digital experience for customers. In this role, you'll partner with the...
  • 16 Days Ago

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Documentation Specialist
  • pfizer
  • Rocky, NC FULL_TIME
  • Documentation Specialist - 1st Shift (M - F with some Saturdays as needed)Summary:The Batch Record Specialist manages the printing and assembly of production batch records based on the Materials Manag...
  • 12 Days Ago

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Documentation specialist
  • RBC
  • Raleigh, NC FULL_TIME
  • Job Description What is the opportunity? This position supports the Wealth Management Credit and Lending Services team for the New York Credit Branch within US Wealth Management by reviewing documenta...
  • 1 Month Ago

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Qualification Documentation Specialist (FT)
  • Adecco Life Sciences
  • Raleigh, NC FULL_TIME
  • SKAN, headquartered in Switzerland with a strong US presence, is a global leader in the pharmaceutical industry for its cleanroom equipment. This equipment is routinely used in vaccine development, pr...
  • 24 Days Ago

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Digital Documentation and Communications Spec
  • Durham Coca-Cola Bottli
  • Durham, NC FULL_TIME
  • SUPERVISES: This individual supervises no staff MAJOR WORKING CONDITIONS: Ordinary office conditions; exposure to warehouse and distribution environments. Internal contacts are with Human Resources st...
  • 1 Day Ago

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0 Documentation Manager jobs found in Raleigh, NC area

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Corelation Keystone Programmer - Remote
  • iO Associates - US
  • Raleigh, NC
  • I am looking to speak to Corelation Keystone programmers with additional experience with Jaspersoft and C# or PowerShell...
  • 3/28/2024 12:00:00 AM

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TMF and Document Associate
  • AA2IT
  • Raleigh, NC
  • Title - Clinical Trial Document Specialist Location - Remote EST (Raleigh, NC preferred) Duration - 6 months Pay Rate - ...
  • 3/28/2024 12:00:00 AM

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Technical Writer
  • Novozen Healthcare LLC
  • Clayton, NC
  • Job Description: The Technical Writer will play a crucial role in developing technical documents for internal department...
  • 3/28/2024 12:00:00 AM

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Physical Therapist
  • REAP Healthcare Agents
  • Raleigh, NC
  • Immediate need for a Physical Therapist to join a well established Pain group. Lets Discuss looking for a full-time outp...
  • 3/27/2024 12:00:00 AM

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Corelation Programmer - Predominantly Remote
  • iO Associates - US
  • Raleigh, NC
  • I am looking to speak to Corelation Keystone programmers with additional experience with Jaspersoft and C# or PowerShell...
  • 3/25/2024 12:00:00 AM

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Legal Assistant
  • Russell Tobin
  • Raleigh, NC
  • Job Description Job Description Our client, a mid-size regional defense firm is looking for a Litigation Legal Assistant...
  • 3/25/2024 12:00:00 AM

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Validation Engineers - Entry/Mid-Level
  • STELLAR CONSULTING GROUP LLC
  • Raleigh, NC
  • Job Description Job Description Validation Associates is currently in search of Validation Engineers for our pharmaceuti...
  • 3/25/2024 12:00:00 AM

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Administrative Assistant
  • Robert L Gomez CPA PC
  • Garner, NC
  • Job Description Job Description Job description You must have recent previous proven track record with Administrative As...
  • 3/24/2024 12:00:00 AM

According to the United States Census Bureau, Raleigh occupies a total area of 144.0 square miles (373.0 km2), of which 142 square miles (369 km2) is land and 0.97 square miles (2.5 km2), or 0.76%, is covered by water. The Neuse River flows through the northeast end of the city. Raleigh is located in the northeast central region of North Carolina, where the Piedmont and Atlantic Coastal Plain regions meet. This area is known as the "fall line" because it marks the elevation inland at which waterfalls begin to appear in creeks and rivers. As a result, most of Raleigh features gently rolling hil...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Documentation Manager jobs
$123,180 to $155,850
Raleigh, North Carolina area prices
were up 1.5% from a year ago

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