Quality Risk Management Business Specialist (Remote / Contract)

Posted 4 weeks ago



Our client, based in Boston MA, Quality Risk Management (QRM) Business Specialist, for a 6 month contract.

Start: 8/15/2022
End: 2/10/2023


Rate: $65/hour

Position Overview:

Our client is seeking a talented Business Data Analyst to join the Quality Risk Management (QRM) team. This role will be focused in ensuring that the Quality Risk Management (QRM) processes are followed across all Functions and Business Units.

One of the key objectives of this role will be focused on gathering QRM files, documenting, analyzing, and determining any gaps with the current QRM processes as part of a CAPA, and liaising/collaborating with stakeholders, subject matter experts, and other team members to align them with the current processes. Also assist in presenting the progress and results of the analysis and deliver QRM training to stakeholders as required

Key Responsibilities:

  • Compile data and develop analysis to support Quality Risk Management file remediation/gap assessments.
  • Engage with stakeholders and identify gaps in the Quality Risk Management files in alignment with the current QRM processes.
  • Assist in the solution implementation for a CAPA.
  • Assist in conducting & establishing trending analysis of the gaps.
  • Experience investigating and solving complex technical problems, root cause analysis, and data discrepancies.
  • Ability to work collaboratively, raise issues in a productive way, and reach consensus in cross-functional settings.
  • Operates independently and/or part of a larger project team to fulfill tasks with little direction, documents results.
  • Assist in presenting results of the gap assessments or training when needed.
  • Record Meeting Minutes and Decisions when needed.
  • Perform other related duties and special projects as required or requested.

Required skills:

  • 2 to 4 years of experience in biopharmaceutical/pharmaceutical or related industry
  • Bachelor’s degree in chemistry, life sciences, engineering, business, or related field
  • Experience gathering, owning, and tracking changes to completion
  • Experience in implementing CAPA solution as owner or part of the team
  • Comfortable working independently as an individual contributor and/or part of a larger project team
  • Ability to work in a Global Team structure
  • Familiarity with QMS technologies including Veeva and other E-Systems
  • Expert use of Microsoft Excel and comfortable with large amount of data
  • Strong interpersonal communication skills
  • Passion for continuous improvement and demonstrated problem solving skills
  • High attentiveness to detail

Preferred Qualifications:

  • Broad understanding of Quality Risk Management (ICH Q9)
  • Direct experience as CAPA owner
  • Knowledge of cGMPs, GXPs and Quality Systems
  • Expert use of Smartsheet Project Management Tools or ability to rapidly learn
  • Experience in delivering training to a broad audience
  • PMP or Six Sigma Certificate a plus