Quality Assurance (QA) Compliance Specialist II
Location/Site – 100% onsite in Waukegan, IL 60085
6+ month contract with the possibility for extension
Hourly Pay Rate: $33/hr (individual medical benefits available at a cost)
Work Schedule: Normal first shift working hours: 8 am to 4:30 pm. There is an opportunity for some flexibility. Training will be onsite.
Orion Group and our largest US client have an exciting contract opportunity for Compliance Specialists in North Chicago. Don't pass on this amazing opportunity to join a market leading pharmaceutical company!!!!
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.
Top 3-5 skills needed:
· 4+ years QA 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,
· Experience with SAP, Soltraqs/Trackwise.
· 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:
· Experience in Quality, Change Control, CAPA, Operations, Documentation
· Excellent English speaking abilities - written and oral communication
· Detail oriented, adaptable, flexible, organized, time management skills, problem-solving skills, works well independently and cross- functionally in a fast-paced industry environment.
What is a nice to have (but not required) skill, experience, education, or certification?
A candidate with previous supplier change notification experience will be preferred.
Is overtime offered or required?
Based on business need
In what type of environment would this individual be working in?
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.
Job Type: Contract
Pay: $29.00 - $33.00 per hour
Benefits:
• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance
Application Question(s):
• Do you have supplier change notification experience? (preferred skill)
Education:
• Bachelor's (Required)
Experience:
• Regulatory Pharmaceutical Industry: 4 years (Preferred)
• SAP, Soltraqs/Trackwise: 4 years (Preferred)
• CAPA: 4 years (Preferred)
Language:
• English (Required)
Ability to Commute:
• Waukegan, IL 60085 (Preferred)
Work Location: Hybrid remote in Waukegan, IL 60085
