Manufacturing Support Specialist


Manufacturing and Production

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Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435



Job Description

The Manufacturing Support Specialist is responsible to facilitate the Deviation Reporting Program in Manufacturing Operations. This includes participating in a team to drive investigations related to manufacturing, packaging and equipment to determine root cause, impact, and corrective/preventative actions (CAPA).

Essential Duties:

* Collaborates with manufacturing and packaging and other cross-functional team members to define root cause and provides recommendation for corrective and preventive actions.

* Monitors, investigates deviations and determines corrective and preventive actions to appropriate company authorities to modify existing manufacturing or packaging processes based upon trend, deviation and related analyses.

* Participates in daily Deviation meeting and provides updates to active, open deviation investigations.

* Coordinates follow-up activities necessary for closing deviation and CAPA investigations.

* Support internal, external and regulatory inspections including FDA, EMEA, and third-party audits related to the Deviation Reporting Program.

* Write and enhance applicable department SOP's and guidelines.

* Responsible for technical writing activities to ensure clear concise investigation summaries.

Education & Experience Requirements:

* A Bachelor's degree is required with a minimum of 3 years' experience working in manufacturing support or quality assurance role, preferably in a regulated


* 2 years of technical writing experience required

This is a Contract to Hire opportunity

Location: Maple Grove, MN - some training in Plymouth

Compensation: $37/hour