Overview
Quality Assurance/QA Compliance Specialist Jobs in Waukegan, Illinois, USA at Rangam Consultants Inc.
Position: Quality Assurance (QA) Compliance Specialist
100% Onsite—-hybrid can be negotiated in the future based on performance
Manager updates:
Position is in the global supplier change team
Looking for someone with change management, change control
Looking for experience in Quality system
Previous supplier change notification will be preferred.
Documentation experience
CAPA experience
Track-wise, SAP experience
Global supply change notification in the mail
Bachelor’s degree is must have
Masters is preferred
QA with change experience will work with SAP Trackwise, SolTRAQs
2 to 3 years’ experience in quality system will work
What are the top 3-5 skills, experience or education required for this position:
4+ years experience.
Bachelor’s Degree in a 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 a 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.
In what type of environment would this individual be working:
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.
Daily Work Schedule Expectations:
Normal first shift working hours: 8 am to 4:30 pm.
There is an opportunity for some flexibility.
NOTE:
While training, the candidate may be asked to begin the day no later than 7:00 am, as training will be provided by someone in Ireland’s time zone. This will improve the availability of trainer/trainee to meet. Also, training will be onsite.
Is overtime offered or required?
Based on business needs.
Does this position offer the ability to work remotely on a regular basis or is it required to be onsite?
No. However, once the candidate is trained and demonstrates the ability and commitment to work independently, it is possible to negotiate work off-site on a hybrid model for 2 of 5 days/week.
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 to 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, GTW, SolTRAQs, One Track.
Initiate Change records to drive change management.
Support collection of information and feedback across manufacturing sites and affiliates.
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Title: Quality Assurance/QA Compliance Specialist
Company: Rangam Consultants Inc.
Location: Waukegan, Illinois, USA
Category: Quality Assurance – QA/QC (Data Analyst)
