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
Change monitoring, implementation and closure.
Also responsible for maintaining hard copy records and storage areas.
Performs other duties necessary.
Yrs of related experience:
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
Affymetrix - 22 months ago