QA Specialist II - Risk Management

Title: QA Specialist II - Risk Management

Work Location: Worcester, MA 1604

Assignment Duration: 12 Months

Hybrid Position

• Science-related background
• Background in GMP manufacturing
• Experience in a QA role
• Experience in Risk Management
• Good oral and written communication skills, ability to work with cross-functional teams

Supports activities and initiatives of the quality organisation to implement and manage the quality risk management activities, as well as leading different QRM-related job tasks. This role will document evaluations relevant to commercial product risk for biologic drug substances, general site risk, risk associated with cross-contamination, facilities, utilities and equipment risk as relevant to assigned responsibilities. Working knowledge of ICHQ9 and Annexe 1 helpful.

The primary responsibilities will be collaborating with technical experts to update risk management documentation, ensuring timely periodic review of risk documents and assisting in revision when appropriate.

• Provide project support to the Cross Functional Team and help to facilitate risk documentation as needed for projects related to risk, continuous improvement, or investigations.
• Monitor and track open action items from the quality risk management activities, ensuring they are implemented as required.
• Monitor periodic review, obsolete documents as necessary, maintain risk documentation and updates as needed.
• Analyse data from multiple sources to identify common trends and identify areas for improvement.
• Prepare reports to document the outputs of risk management monitoring activities, if required.
• Escalate Risk
  - Use sound judgement to identify novel events, new risks or changes to the risk profile, make recommendations to elevate or provide a rationale why escalation is not necessary.
• Support QA Compliance activities as needed ( Investigations, audits, etc).

• Bachelor's degree in Science.
• 3-5 years of GMP experience, preferably in Biologics; risk management experience beneficial.
• Effective verbal and written communication skills.