Title:  NCR Specialist

Who We Are:

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

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.
 

#LI-KR1

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.