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QA CAPA Specialist

Edison-New Brunswick Metro Area, NJ

Post Date: 04/03/2018 Job ID: JN -042018-21259 Job Type: Scientific
QA Specialist - CAPA and Investigations
Support major deviations/investigations and CAPA s in regards to Manufacturing Operations

Responsible for assisting in developing and maintaining various programs and systems to ensure compliance and quality. This may include but not be limited to training, trending and continuous improvement endeavors.

Under the direction of the Manufacturing Operations Continuous Improvement Team, work cross-functionally to perform the following:
B.S. in a scientific or engineering discipline
2 or more years relevant experience, preferably in a GMP or regulated environment
-Experience writing deviations and investigations required.
Initiate deviations and perform routine investigations
Participate in cross functional investigative teams deploying specific investigative principals
as necessary to ensure root cause analysis and corrective action(s)
Ensures corrective actions and improvements are shared and incorporated into the
appropriate processes
Generate and execute CAPA documents to support response to deviations, audit findings and
independent corrective actions

Collaborate with QC team to prioritize and lead Continuous Improvement initiatives
Basic understanding of site quality systems
Generate risk assessment as necessary to support deviations, CAPA,
SOP revision, and program development
Basic knowledge of cGMPs
Basic knowledge of flow cytometry and microbiology techniques

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