West Pharma NCR Specialist 

United States, Arizona, Phoenix 

7979946

Job Summary:

Responsible for the process of non-conforming material, which includes the generation, evaluation, investigation, disposition, and completion of Quality Notifications. This also includes generating, updating, and/or reviewing work instructions while maintaining compliance to all regulatory requirements.

Essential Duties and Responsibilities:

• Support the Manufacturing Quality Assurance team including the Quality Manager, Engineers, and Supervisors.
• Perform investigations of defective material and determine the scope of the affected product(s).
• Coordinate with suppliers/ buyers on defective RMA.
• Monitor the effectiveness of the process, identifying and implementing process improvements.
• Create and maintain issue reviews for all Non-conformances
• Effectively communica te with all levels of associates within the organization, including engineering, supplier quality, purchasing, and quality assurance
• Coordinate rework of returned product, suspect internal product and
• Oversees the process of non-conformity reports.
• Present reports of monthly metrics of open and closed non-conformance reports
• Communicates with cross-functional teams.
• Completes risk analysis for product disposition
• Assessments, issue, and corrective actions management
• Maintains a strong understanding of Good Manufacturing Practice (GMP) and ISO13485 requirements.
• Exhibits regular, reliable, punctual, and predictable attendance.
• Performs other duties as assigned by the Quality Supervisor or Manager.

Basic Qualifications:

• Education or Equivalent Experience: High school diploma or equivalent.
• 2 or more years of experience in Quality or similar role.
• Proficiency with PC and Microsoft Office; Knowledge of QAD-SAP, Master Control or other Quality system is preferred.
• Strong attention to detail; Strong problem identification/analysis and solving skills with hands-on approach.
• Excellent verbal and written communication skills; Maintain an organized workstation.
• Ability to multi-task and prioritize in a fast-paced environment; Ability to interface with all personnel levels.
• Motivated self-starter with ability to work independently on multiple assignments in a team environment
• Willing to work as a team and make decisions within authorized responsibility with little to no supervision.

Preferred Knowledge, Skills and Abilities:

• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary.
• Sitting and/or standing for extended periods of time may occur as well.
• If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.
• Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet.
• The ability to be able to lift and carry various items up to 50 pounds for manufacturing positions or 30 pounds for administrative positions is required.

Travel Requirements:

• None.

Physical and Mental Requirements:

• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary.
• Sitting and/or standing for extended periods of time may occur as well.
• If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.
• Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet.
• The ability to be able to lift and carry various items up to 50 pounds for manufacturing positions or 30 pounds for administrative positions is required.