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7 Oct 2020

Temporary Lead QA Technical Operations (20-15509)

Axelon Services Corporation – Posted by iris.chen@axelon.com Devens, Massachusetts, United States

Job Description

Responsibilities:
• Provides quality support to Devens Site through quality review and approval of investigations and change controls. Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of the manufacturing process including, incoming, manufacturing, facility, and utility systems.
• Assures consistent, effective use of the site change control system for all change requests. Ensures supporting documentation and change deliverables meet external regulatory and internal WWQC guidelines and requirements.
• May provide Quality support of technical services programs.
• Represents QA in cross-functional meetings

Qualifications:
• Knowledge of science generally attained through studies resulting in a B.S. in Science, Engineering, Biochemistry or related discipline or its equivalent is preferred
• Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
• Knowledge of US and EU cGMP regulations and guidance.
• Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, SmartLAB and Syncade desirable.
• Past experience where one was required to work in a team based environment with a diverse group of people.
• Excellent writing and oral communication skills are required.

How to Apply

Please send your updated resume to iris.chen@axelon.com

Job Types: Temporary.

Job expires in 67 days.

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