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Ecocareers · 17 hours ago

QA Specialist- Risk Management

Worcester, MA

Full-time

Onsite

Mid Level

3+ years exp

Ecocareers is a company focused on quality risk management within the pharmaceutical industry. They are seeking a QA Specialist to implement and manage quality risk management activities, document evaluations, and collaborate with technical experts to ensure compliance and continuous improvement.

Staffing & Recruiting

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

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.)