Document Control Specialist

3 weeks ago

Raleigh, United States Proesis Bio Full time

Proesis Biologics is a contemporary and forward-thinking human source plasma collection platform dedicated to improving the plasma donation journey for all stakeholders. We partner with communities and donors to supply the industry with the high-quality plasma necessary for treating people with rare and chronic conditions worldwide. We strive to create a collaborative and engaging culture focused on bold authenticity, intense curiosity and innovation, fierce donor advocacy, and growth.

Proesis Bio is looking for a Document Control Specialist residing in the Raleigh/Durham, NC area to participate in a 10-15 hours per week paid internship through December. This internship will be both remote and onsite, meeting to work in person with other Proesis teammates as needed. The ideal candidate for the role will have experience working with document and change control, preparing, and submitting redlines, as well as strong proof-reading skills and strong attention to detail.

Enough with the formalities. Are you ready to work for an organization that truly values you as a person, not just a worker? We don't simply say our employees are our most valuable resource, we live it with emphasis on providing outstanding benefits related to your time (our PTO and paid Holidays are legit); health and dental insurance; wages (some sources show we pay in the top 10-15% of the market); and much, much more. By joining our team at Proesis Bio, you will not only be embarking on an exciting professional journey, but you'll also have the chance to make a real, tangible difference in the lives of people across our global communities, each and every day. If we have your attention, please continue reading to learn more about the role.

Requirements

Role and Requirements:

Document Control Responsibilities:

Perform the following duties to aid in the SOP / document revision and creation process in conjunction with the Document Control Manager:

  • Prepare and submit requested document drafts to authors / Subject Matter Experts (SMEs)
  • Process completed document drafts by reviewing the submitted draft redlines for completion which includes, but it not limited to:
  • Ensuring that the document redlines match the requested changes per the associated Change Request (CR)
  • Editing documents for grammar and errors such as spelling, incorrect pagination, punctuation, etc.
  • Assist authors / SMEs in the writing process when required (i.e., if the author has trouble with formatting tables, flowcharts, etc.).
  • Route / send reviewed documents to the Document Control Manager for final document review
  • Conduct periodic document audits under the direction of the Document Control Manager
  • Provide Document Control Customer service when necessary
  • Attend SOP Revision Meetings when requested (may include documenting meeting minutes)
Change Control Responsibilities:
  • Manage Change Requests (CRs) lifecycles via the Proesis Bio Change Control Module from submission to closure including maintenance of any CR logs and / or files
  • Provide Change Control Customer Service when necessary
  • Attend Change Control Review Committee meetings when requested (may include documenting meeting minutes)
Qualifications and Education:
  • High school diploma
  • Available to work flexible and/or extended shifts as needed.
  • Flexibility to work outside of normal business hours.
  • Must demonstrate a strong work ethic, excellent communication, and organizational skills.
  • Demonstrated ability to work with computer-based applications and software.
  • Demonstrated history of working in compliance-driven environment.
  • Customer -service and goal oriented
  • Ability to adapt to immediate changes and work in a fast-paced environment while maintaining composure.
  • Ability to communicate effectively (clearly, concisely and with tact) with others.

Minimum Software Levels:
  1. MS Word - Advanced
  2. MS Excel - Intermediate
  3. MS PowerPoint - Basic - Intermediate
  4. MS Visio - Basic
  5. Adobe Professional - Basic - Intermediate

At Proesis, we don't just accept difference - we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community.

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