Exemplar Global Career Center

Quality Assurance Specialist

Dicerna
Lexington, Massachusetts, United States
10 days ago

Description

We are seeking a Quality Assurance Specialist who will manage and oversee the Document Control aspects of Quality Assurance and will assist with other QMS responsibilities.  They must have a working knowledge of QMS and its responsibilities and be a self-starting problem solver who drives results through high compliance and a positive work style ensuring quality activities are carried out according to the regulatory requirements.

Key Responsibilities

  • Ensure quality activities are carried out according to the regulatory requirements.
  • Drive Document Management System tasks to completion.
  • Assist in the execution of other QMS responsibilities as needed (i.e. CAPA, Change Control, and Quality Events)
  • Assist in facilitating and conducting trainings related to the electronic document management system in coordination with QA Training.
  • Editing document for consistent formatting and working with content owners to ensure quality document.
  • Coordinate workflows with task owners to ensure that documents are properly reviewed, issued, approved, and obsoleted within needed timeframes.
  • Follow up with others to ensure that records are completed and documented within established timeframes.
  • Execute Administrative tasks for Veeva Quality Vault including but not limited to user provisioning and periodic system updates/maintenance.
  • Be a self-starting problem solver who drives results through high compliance and a positive work style.
  • Additional responsibility for execution and maintenance (data entry, metric reporting, filing, archival) of assigned quality system.
  • Performs related duties as required.


Requirements

Qualifications

  • Bachelor’s degree or equivalent experience
  • At least >3 years of experience in the pharmaceutical/biotech industry. At least 3 years of document management experience in a Quality Assurance related function.
  • Must have excellent abilities with intermediate MS office concepts such as Word Styles, cross-references, keep with next, section breaks, freeze panes, header/footer and others
  • Experience with Veeva Vault or other electronic document and quality management system is preferred.
  • Knowledge of GLP, GMP, GCP, Part 11 regulations, FDA Guidances for Industry, EU regulations, and other standards.
  • Strong proofreading and document formatting skills which must include processing of controlled documents (new documents, revision, obsolescence, etc.)
  • Strong problem solving/analytical skills.
  • Ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism.
  • Excellent written and verbal communication skills, strong organizational skills, strong negotiation, analytical and decision-making skills, and attention to detail
  • The ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.
  • Strong organizational skills, with the ability to handle multiple tasks.

Job Information

  • Job ID: 59824558
  • Location:
    Lexington, Massachusetts, United States
  • Position Title: Quality Assurance Specialist
  • Company Name: Dicerna
  • Job Function: Quality Assurance
  • Job Type: Full-Time
Cambridge , MA , US

Dicerna is working to improve the lives of people suffering from diseases involving the liver, including rare diseases, viral infectious diseases, chronic liver diseases, and cardiovascular diseases. We discover and develop innovative RNA interference (RNAI)-based therapies to stop or turn off destructive disease processes by silencing the genes underlying these processes.

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