New

QA Specialist II - Risk Management

Spectraforce Technologies
United States, Massachusetts, Worcester
Jan 12, 2026
Description: Title: QA Specialist II - Risk Management Work Location: Worcester, MA 1604 Assignment Duration: 12 Months What are the top 3-5 skills, experience or education required for this position: Hybrid Position 1. Science-related background 2. Background in GMP manufacturing 3. Experience in a QA role 4. Experience in Risk Management 5. Good Oral and written communication skills. Ability to work with cross-functional teams Sumary 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. Additional Responsibilities- 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 escalate or provide a rationale why escalation is not necessary. Support QA Compliance activities as needed ( Investigations, audits, etc.) Qualifications: * Bachelor's degree in Science. * 3-5 years of GMP experience, preferably in Biologics, risk management experience beneficial. * Effective verbal and written communication skills