Document Control Coordinator
Affymetrix - Cleveland, OH

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Position Summary:
Implement and manage the Affymetrix Change Order system and control and organize records.

Primary Duties and Responsibilities:
Responsible for ensuring compliance with internal policies and procedures as well as regulatory agencies requirements applicable to the products and documents.

Primary focus related to the following functions:
Change Order initiation

Change review and approval

Component dispositioning

Change monitoring, implementation and closure.

Also responsible for maintaining hard copy records and storage areas.

Performs other duties necessary.

Requirements:
Required

Preferred

Education:
HS Diploma/GED

HS Diploma/GED

Yrs of related experience:
One year

One Year

Competencies: (skills, knowledge, abilities)

Strong team work and communication

Excellent planning and scheduling skills

A fundamental working knowledge of safety, quality systems, and quality assurance concepts is required including the application of current Good MFG Practices (cGMPs) and Food and Drug (FDA)

Knowledge and background of PDM and ERP/MRP systems a plus (e.g. JDE)

ISO 13485:2003 training preferred

Excellent command of English language, spelling and grammer

PDM, ERP/MRP, cGMP

ISO 13485:2003 training

Licenses/Certificates:
N/A

N/A

Travel Requirements:
N/A

N/A

Working Conditions:
N/A

N/A

Affymetrix - 22 months ago - save job - block
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