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Job Description

Title: Quality Specialist - II
Location: Rahway, NJ
Duration: 12+ Months
Note: 12 months assignment, Hybrid (3-4days onsite/week). Possibility of extension.

Department is responsible for starting up new clinical manufacturing facility for sterile products and is seeking a strong quality professional to perform the below tasks:
The primary role of this position is to support Operational Readiness of the new Client Research Labs sterile clinical manufacturing facility in Rahway, NJ.
The individual will work closely with Operations partners to develop processes and procedures which meet all internal and external quality and compliance requirements.
A core part of this position is to serve in the lead (or co-lead) role for Quality Risk Assessments.
As the lead/co-lead, the individual will work with Operations partners to develop the Plan for each risk assessment. They will then schedule and run cross-functional risk assessment meetings.
As the lead/co-lead, they will be responsible for reporting the outcomes of the risk assessment. This includes a written report(risk assessment) and a presentation to the appropriate Decision Makers.
The individual will support other aspects of Operational Readiness, as it pertains to quality deliverables. This may include authoring or reviewing documents like SOP's, training materials etc. It may also include designing and/or utilizing project management tools to track progress.
The role will require some on-site presence at the Rahway site, primarily for leading face-to-face meetings (e.g., risk assessments).

Quals--
Education:
Bachelor's of Science or Master's degree. Technical emphasis in an appropriate scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience.

Required Experience and Skills:
At-least 4years of relevant experience with BS and 2+ years with Master's.
Need an individual with either Project Management experience, Quality Risk Management experience, or preferably both.

Software: MS office(Basic)

Personality:
Team Player
Strong communicator(verbal and written)
Detail oriented
Someone who can value listening to multiple perspectives.
Strong time management skills
Can manage Multiple deliverables at one time.