Supplier Change Notification Specialist

Description

Position Title – Quality Assurance (QA) Compliance Specialist II

Work shift (days/times) – Normal first shift working hours: 8 am to 4:30 pm. There is an opportunity for some flexibility. Training will be onsite.

100% Onsite

Job Title: Specialist, Quality Systems

Purpose:

The candidate is responsible for providing quality assurance support for some or all parts of the Supplier Controls Quality System. Specific areas of support include Supplier Change Notification assessment, initiation of change control/change plan activities, and request/collection of feedback from manufacturing sites and affiliates. The person will ensure compliance with the quality system as it pertains to Supplier Change Notifications.

Responsibilities

• Monitor global Supplier Change Notification inbox for change notifications
• Evaluate Change Notifications to determine impacted materials and manufacturing sites using SAP, OneTrack
• Initiate Change records to drive change management
• Support collection of information and feedback across manufacturing sites and affiliates.

Are you open to looking at candidates willing to relocate at their own expense? No

Top 3-5 skills needed –

• 4+ years’ experience. Bachelor’s degree in science or engineering field. Master’s preferred but not required.
• Experience in quality systems e.g. change controls, supplier management, deviations, documentation, CAPA, audits, experience with supplier change notifications, searching vendors in SAP, Soltraqs/Trackwise experience.
• Experience in the Regulatory Pharmaceutical Industry.
• Experience in managing and finding resolutions from complex situations or that are not well defined, in a timely fashion.

Skills:

• Excellent written and oral communication skills, detail oriented, adaptable, flexible, organized, time management skills, problem-solving skills, works well independently and cross- functionally in a fast-paced industry environment.
• English is the first language
• Experience in Quality, Change Control, CAPA, Operations, Documentation

What is a nice to have (but not required) skill, experience, education, or certification?

A candidate with previous supplier change notification will be preferred.

Is overtime offered or required? Based on business need

In what type of environment would this individual be working (i.e.: Team; Individual; type of office, etc.) ?

 Office setting. Much of the work can be performed independently, but there will be a need to meet and interact with the team for training and general communication.