QA Specialist II

The Fountain Group is a national staffing firm and we are currently seeking a QA Specialist - Risk Management for a prominent client of ours. This position is in Worcester, MA 01605. Details for the position are as follows:

Job Title:

QA Specialist – Risk Management (Senior QA Associate considered based on experience)

Location:

Worcester, MA

Schedule:

Hybrid
Pay Rate: $43–$46/hour

This role supports the Quality organization’s Quality Risk Management (QRM) activities within a GMP biologics manufacturing environment. The position is highly documentation-driven and compliance-focused, requiring close collaboration with cross‑functional technical teams to assess, document, monitor, and maintain risk management activities.

A candidate with a science‑based background who is comfortable working in regulated environments, managing complex documentation, and applying risk‑based decision‑making will be an excellent fit.

• Support and lead Quality Risk Management (QRM) activities across commercial biologic products and site operations.
• Develop, update, and maintain risk management documentation related to:
  • Biologic drug substances
  • Site and operational risk
  • Cross‑contamination risk
  • Facilities, utilities, and equipment risk
• Apply working knowledge of ICH Q9 (Quality Risk Management); familiarity with EU GMP Annex 1 is a strong plus.
• Collaborate with technical subject matter experts to ensure risk documentation is accurate, current, and reviewed on schedule.
• Perform periodic reviews of risk documents, manage document revisions, and identify obsolete records.
• Track and monitor open action items resulting from risk assessments and ensure timely implementation.
• Analyze data from multiple sources to identify risk trends, recurring issues, and opportunities for improvement
  .
• Prepare reports summarizing outputs of risk management monitoring activities.
• Exercise sound judgement to escalate risks appropriately
  , including documenting rationale when escalation is not required.
• Provide QA compliance support as needed, including:
  • Investigations
  • Audits and inspection readiness
  • Continuous improvement initiatives