Quality Assurance Specialist - Risk Management

Location: Cambridge, MA
Department: Azzur of NE, LLC

Job Description

Responsibilities:
  • Provide in-depth understanding and application of pharmaceutical quality risk management practices and approaches in design and manufacturing environments.
  • Familiarity with global regulatory agencies’ requirements for Quality Risk Management and Quality Systems (ICH Q9, GAMP5, 21CFR 11/210/211, ISO 14971).
  • Demonstrate working knowledge of quality risk management tools, including FMEA, PHA, RR&F.
  • Demonstrate the ability to facilitate and support cross functional teams to drive risk assessments.
  • Leads teams in identifying mitigations and ensuring traceability of identified mitigations.
  • Author risk management documents, SOPs, Work Instructions, Templates.
  • Maintain QRM library, risk register and other databases for Risk Management program.
  • Support with data gathering and compilation for metric reporting.
  • Proactively engage partners to drive consensus and resolve issues in a timely fashion.

Requirements:
  • Must be able to prioritize, manage and follow-up on numerous projects and activities.
  • Must exhibit effective interpersonal, written, and verbal communication skills.
  • Must be detail oriented and exhibit a high degree of flexibility and initiative.
  • Ability to think critically, and utilize troubleshooting and problem-solving skills.
  • Cell & Gene Therapy knowledge or experience is a plus.



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