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Associate, QA-GCP
Ref No.: 18-12315
Location: Cambridge, Massachusetts
• Obtain, trend and analyze quality metrics that monitor drug development activities
• Obtain, track and document audit information and associated documents
• Assist in process improvement mapping• Aide in root cause analysis and resolution
• Assist QA management in the development and implementation of Vendor Management strategy to ensure continuous quality improvement, providing input to management and taking the initiative, as appropriate.
• Learn about GxPs in relation to pharmaceuticals and apply them to everyday tasks
• Support inspection readiness activities
• Train on all relevant procedures, as appropriate
• Train on auditing processes and conduct
• Assist in preparation, conduct and follow-up of audits
• Assist in controlled document revisions
• Attend group meetings, as applicable
• Other assignments as directed by Quality Management

• Ability to identify quality issues/discrepancies, and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.
• Demonstrated good judgment and decision-making experience.
• A clear understanding of risk management principles
• Must have excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines.
• Must have strong written and oral communication skills.