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Job Post Index 2663C2-Sy##
Location North Chicago, IL
- Follow the Quality guideline (QCM01-01-001-G001) and serve as the “Change Owner” and drive both the set-up and completion of the Change Plans for Key Product Life Cycle activity. (i.e. product discontinuations)
- Work with the Operations Brand Managers and the full Cross Functional Team (CFT) to identify all critical information needed for the Change Plan (CP) (timing, full scope, specific product information, name of the Supply Chain Planner, etc.)
- Set up Project Planning meetings, invite key areas listed in the guideline (and know who to contact for the meeting)
- Discuss the key topics listed in the Quality guideline (scope, timing, impact to sites/affiliates….)
- Request action items (information needed to populate the Change Plan and tasks) from the core Cross Functional Team (CFT) and follow up if they do not provide the information
- Go through the Potential task list with the team to determine which tasks would be needed for the CP
- Request the team identify the main information for each task (Task Owner, Task Approver, Task due date)
- Populate the Change Plan per QCM01-01-001 (with specific examples and guidance from QCM01-01-001-G001).
- Basically, every field other than Regulatory, would be filled out by the Change Owner, and ALL tasks identified would also be created
- Perform activities in the guideline that may be needed (example: submit a help desk ticket to get a MARC table with all information that would be in the SAP Grid)
- Submit the CP to the Change Coordinator in SolTRAQs (We review and if complete, get Reg assessment, discuss with the CRB for preapproval, set up a CFT meeting to review everything and determine if there are more tasks information needed, route the CP, etc.)
- Attend CRB meetings where applicable to explain CP to the board and follow-up on any questions that may come out of those meetings
- Follow up with the approvers and task owners if they do not close out their activities in time
- Manage the status (A0, A3, A4, A5) of the SAP codes in scope of the CP and work with Master Data Management to ensure the status is updated timely
- Track and escalate to ensure change plans are completed in target timing
- BS degree or 4-8 years equivalent experience
- 4 year of experience pharma, health care, or regulated industry desired
- Experienced in project management
- Demonstrated ability in leading cross-functional teams
- Ability to independently perform Quality System (SOLTRAQS) documentation and SAP capabilities helpful
- Excellent organizational skills, attention to detail, and strong oral and written communications skills
- Independent decision making, triage and escalation of “at risk” projects
- 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.