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Specialist, Continuous Improvement, Manufacturing Operations

Newark Metro Area, NJ

Posted: 04/18/2018 Job Type: Scientific Job Number: JN -042018-21376
The Specialist, Continuous Improvement, is responsible for supporting major deviations/investigations and CAPA s in regards to Manufacturing Operations at CTDO. In addition, they will also be 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.

2. Duties and Responsibilities:

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
MOST IMPORTANT - Experience writing deviations and investigations.
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
Interact and collaborate with departments (on and offsite) as well as vendors, consultants,
and other external services providers
Generate risk assessment as necessary to support deviations, CAPA,
SOP revision, and program development

Basic proficiency in MS Word, Outlook, Excel, PowerPoint, and Visio
Basic critical thinking and decision-making skills
Basic time management, organizational, and multi-tasking abilities
Ability to solve routine complex problems
Basic technical writing and verbal communication skills
Basic knowledge of cGMPs
Ability to work independently without direct supervision and work within cross-functional teams
Basic knowledge of flow cytometry and microbiology techniques

Physical /Mental Demands:
The incumbent will be required to work in an office environment potentially requiring ergonomic

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