Change Control Specialist

2 weeks ago

Waukegan, United States Orion Engineering, Inc. Full time
Job description

Location: Waukegan, IL

Contract Length: 12 Months

Pay Rate: $33-38/hr including individual healthcare coverage

Job Description

Orion Group are partnered with a global pharmaceutical client in Waukegan, IL. for a Change Control Specialist / Project Manager who will be responsible for the management of small to large scale change control projects.
  • Partnering with brand teams for pipeline and on-market teams change plan project execution
  • Experience of supply chain, quality, or regulatory roles within the pharmaceutical industry would be highly preferred
  • Candidates MUST have a strong understanding of the required documentation for change control projects
  • Experience with documentation workflow tools would be highly preferred
Day to Day Responsibilities
  • 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)
During the meeting(s):
  • 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 change plan
  • 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).
  • Perform all 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
Improvement Opportunities:
  • Maintains listing of improvement opportunities, (e.g. automation, templates, elimination of steps)
  • Prioritizes initiatives.
  • Develops plan to execute highest priority initiatives.
  • Executes initiatives to deliver process efficiency


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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