QA Specialist- Risk Management

Roles And Responsibilities

• Supports activities and initiatives of the quality organization 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 Annex 1 helpful.
• The primary responsibilities will be collaborating with technical experts to update risk management documentation and ensure timely periodic review of risk documents and assist 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, ensure they are implemented as required.
• Monitor periodic review, obsolete documents as necessary, maintain risk documentation and updates as needed.
• Analyze 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 Client events, new risks or changes to the risk profile, make recommendations to escalate or provide rationale why escalation is not necessary.
• Support QA Compliance activities as needed ( Investigations, audits, etc.)

• 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.

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