Day One Biopharmaceuticals

Document Control and Training Specialist

Day One Biopharmaceuticals

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Salary

💰 $85,000 - $95,000 per year

Job Level

JuniorMid-Level

About the role

  • Maintains a GMP-compliant document management system, to include oversight and auditing of the system.
  • Plans and executes multiple tasks to ensure controlled documents are managed per procedures and applicable regulations.
  • Manages manual electronic signature process .
  • Processes cross functional documents, both electronically and hard copy as needed.
  • Assists with the set-up and changes in systems, ensuring processes are followed.
  • Manages Document Control and Training processes, providing training to personnel as needed.
  • Backup for the Complaints and Change Control processes, providing training to personnel as needed.
  • Administrator for Document Management System and Training Management System.
  • Provides support on various other projects as necessary, ensuring appropriate Document Control is maintained.
  • Provides support during inspection activities.
  • Other duties as required and necessary to ensure the success of the organization.

Requirements

  • 2+ years of R&D, QA/QC, and/or manufacturing experience preferred.
  • BS degree in Science or Engineering preferred
  • Working knowledge of GMP requirements, regulations, and guidance
  • Experience with document management systems (e.g Box, Sharepoint)
  • Knowledge of and skill in using computer software and hardware applications, including Microsoft products (Word, Access and Excel) and electronic document management systems.
  • Skilled in effective communication, written and verbal. Ability to effectively present information and respond to questions from internal customers
  • Skilled in juggling multiple projects while maintaining attention to detail
  • Initiative to jump in and help create solutions to issues found
  • Must be able to use individual discretion in completing work assignments, establishing priorities, and working collectively to accomplish deadlines and objectives.
  • Working knowledge and understanding of GMPs for pharmaceuticals
  • Ability to change direction and respond to new situations which require immediate attention.
Benefits
  • Please visit https://www.dayonebio.com/benefits to see our competitive benefits.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
GMP compliancedocument management systemselectronic signature processdocument controltraining processesR&D experienceQA/QC experiencemanufacturing experienceMicrosoft WordMicrosoft Excel
Soft skills
effective communicationattention to detailinitiativeproblem-solvingability to juggle multiple projectsdiscretionprioritizationcollaborationadaptabilitypresentation skills
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