Department: Quality Assurance
Job Title: Quality Assurance Specialist
Description:
ImmunoGen, Inc. is in search of an experienced Quality Assurance Specialist to join the QA department in our Norwood, MA facility. The Senior Supplier Quality Assurance cGMP Specialist is responsible for ensuring a high level of cGMP compliance in regards to activities associated with Contract Manufacturing Organizations (CMOs) utilized by ImmunoGen. The Senior Supplier QA cGMP Specialist will provide assistance to the Supplier QA cGMP Supervisor as well as serves as a backup for providing cGMP Compliance support to the Norwood facility.
Job duties and responsibilities include:
Reviews and approves Document Change Controls for master batch records and other documentation, as needed
Approves master batch records and other documentation, as needed
Reviews and approves batch records and quality control testing
Reviews and approves planned and minor deviations, reviews major and critical deviations
Reviews investigations
Reviews and approves stability protocols
Assists in performing audits of CMOs
Attends regularly scheduled meetings with various CMOs
Communicates with CMOs regarding documentation issues and expectations
Notifies management of any CMO quality-related issues
Performs tracking and trending of CMO batch record review and QC data review turnaround times
Interacts and is a team player with personnel from various departments in CMO activities
Job Requirements:
The qualified candidate will possess a BS or MS in life sciences with at least 6 years of overall experience in the pharmaceutical/biotechnology industry. At least 4 of the 6 years must have been in Quality Assurance with some experience working with CMOs.
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