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Document Coordinator

2 months ago

Holly Springs, United States CSL Full time

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

You will work onsite in the Holly Springs office and will provide support for paper and electronic records management and archival, according to applicable processes and within the relevant electronic systems. You will be assigned to support local and global improvement initiatives, business projects, and complex document implementations. You will report to the Documentation & Records Management US Regional Lead.Benefits Include Onsite Café, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

Responsibilities

Manage document processes in the electronic Document Management System (DMS)

  • Follow standardized, global DMS administration processes to
  • Review document content for compliance with template standards
  • Format documents
  • Apply release criteria, including verification of any prerequisites
  • Complete reference assessments for document obsoletion
  • Support periodic review workflows
  • Generate standard reports or document listings
  • May provide input to DMS processes, procedures, and training material
  • Support site and function audit preparations with respect to DMS functionality
  • Support local and global improvement initiatives, business projects, or complex document implementations
  • Provides guidance and support to more junior team members and site/function document coordinators within the business

    Support for Paper and Electronic Records Management and Archival

    • Follow standardized, local and/or global records management processes to
    • Receive and process routine or audit document requests
    • Organize, file, log and/or retrieve paper records in onsite records facilities or in electronic document in electronic archival systems
    • Prepare paper documents for offsite, long-term storage or for destruction
    • Reconcile documents going to or coming back from offsite storage
    • Complete periodic reviews of trackers or onsite storage facilities

      CAPAs stemming from audits, inspections, deviations and other Quality related assessments, as well as actions stemming from Change Controls

      • Support investigation of deviations and own CAPAs related to GDMS.
      • Support evaluations of change controls related to GDMS.

        Experience

      • Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.
    • Bachelor's degree in scientific discipline/life sciences preferred, or relevant scientific discipline.
  • 3years of experience in the pharmaceutical/biotech industry, or other highly regulated industry.
Proficiency in MS office and other software programs.Knowledge of cGMP/GXP standards

#LI-Onsite

Our Benefits

CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL Seqirus employee.About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.

We want CSL Seqirus to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.

Do work that matters at CSL Seqirus

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus