Document Management Specialist

Posted 9 Days Ago
Be an Early Applicant
6 Locations
Remote
Junior
Other
The Role
Manage document control within the eDMS (MasterControl) to ensure GxP compliance. Maintain, track, and control quality system documentation, support QA reviews, coordinate cross-functional stakeholders, meet strict deadlines, and assist with regulatory/Notified Body interactions as needed.
Summary Generated by Built In

Job Description:

Document Management Specialist

The Quality Assurance & Compliance Document Management Specialist will ensure compliance with relevant guidelines and regulations in a GxP environment. The position holder, with the input from the line manager and the QA team, is responsible for Document Management in the eDMS MasterControl

Make an Impact at Veristat!

Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.

  • 105+ approved therapies for marketing applications prepared by Veristat
  • 480+ oncology projects in the past 5 years
  • 350+ rare disease projects delivered in the past 5 years
  • Flexible, inclusive culture — 70% remote workforce, 66% women-led teams
  • Learn more about our core values here!

What we look for

  • Bachelor’s Degree in a science or related field required
  • 2-3 or more years of relevant industry experience in Document Control in Quality Assurance
  • 2 or more years of experience in Document Control in MasterControl
  • Working experience in quality system programs
  • Excellent written and oral communication skills
  • Proficient in Microsoft Word, Excel and PowerPoint.
  • Strong multitasking and organization skills with a high level of attention.
  • Demonstrated ability to work in a cross-functional team
  • Well-honed ability to work independently, think critically, take initiative and set priorities, as much as ability to work as part of a team.
  • Ability to meet strict deadlines, flex with changing priorities.
  • Health Authority and/or Notified Body experience a plus

Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

#LI-SI1

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Skills Required

  • Bachelor's Degree in a science or related field
  • 2-3 or more years of relevant industry experience in Document Control in Quality Assurance
  • 2 or more years of experience in Document Control in MasterControl
  • Working experience in quality system programs
  • Excellent written and oral communication skills
  • Proficient in Microsoft Word, Excel and PowerPoint
  • Strong multitasking and organization skills with high attention to detail
  • Demonstrated ability to work in a cross-functional team
  • Ability to work independently, think critically, take initiative and set priorities
  • Ability to meet strict deadlines and adjust to changing priorities
  • Health Authority and/or Notified Body experience
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The Company
HQ: Southborough, Massachusetts
443 Employees

What We Do

Veristat is the science-first full-service drug and biologic CRO and consultancy that integrates strategic planning, regulatory expertise, and clinical trial execution to rapidly advance the most complex or novel therapies. At Veristat, we collaborate with clients to support the rapid delivery of life-changing therapies, helping them make sound decisions amidst uncertainties. Our scientific experts design and conduct the global activities required for any clinical, regulatory, or commercialization program comprehensively and efficiently. ​ With our focus on novel drug development and nearly 30 years of experience, our versatile approach and bold scientific thinking make the impossible possible. Depend on our game-changing expertise and reliable execution for fast results and positive impact to support your biologics and drugs to treat rare cancers, CNS/Neurological disorders, Endocrine/metabolic disorders, and infectious diseases. We are…Bold. Scientific. Versatile. Veristat.​ - Veristat has recently been made aware that unknown third parties that have no connection to Veristat are generating fake Veristat job postings, interviews, and even fake employment offers via emails, websites, and various social media platforms, seemingly for the purpose of fraudulently obtaining personal information from legitimate job candidates. All legitimate correspondence from Veristat will originate from our applicant tracking system (Jobvite) or an @veristat.com email address. If you have received outreach from someone claiming to be a member of our team please search our official LinkedIn company page (https://www.linkedin.com/company/veristat-llc), where all members of our authorized recruiting team can be identified, or contact us directly at [email protected]. Be vigilant

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