Quality Systems Specialist - #1400308

Responsibilities

• 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.
• Ensure compliance to the quality system as it pertains to Supplier Change Notifications.
• Monitor global Supplier Change Notification inbox for change notifications
• Evaluate Change Notifications to determine impacted materials and manufacturing sites using SAP, GTW, SolTRAQs, OneTrack
• Initiate Change records to drive change management
• Support collection of information and feedback across manufacturing sites and affiliates.
  
  

Requirements

• Bachelor's Degree in a Science or Engineering field.
• Master's preferred but not required.
• 4+ years experience
• 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.
• Excellent written and oral communication skills, detail oriented, adaptable, flexible, organized
• Time management and 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
• Previous supplier change notification will be preferred.
• Normal first shift working hours: 8 am to 4:30 pm.
  
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.