Associate QA

Cambridge, MA | Contract

Post Date: 08/09/2018 Job ID: 227032 Industry: IT

Development Associate II 

Associate QA  is required for a  contract  position in  Cambridge, MA




• 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


Required Skills:

• 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.


Required Experience & Education:

Bachelor’ s Degree (BA/BS), preferably life science with exposure to GCP Quality Systems that support pharmaceutical development, or pre-graduate experience as Co-op in the same environment


Duration: 3 months 
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