Quality Control Specialist

Quality Control Specialist#26-06725 North Chicago, IL All On-site Job Description Description 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) o Discuss the key topics listed in the Quality guideline (scope, timing, impact to sites/affiliates.

...) o 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 o Go through the Potential task list with the team to determine which tasks would be needed for the CP o 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 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 Description Details
• Are you open to look at candidates willing to relocate? No,
• Years of experience/education and/or certifications required: BS degree or 4-8 years equivalent experience
• What are the top 3-5 skills requirements should this person have?

1: Experienced in project management 2: Demonstrated ability in leading cross-functional teams 3: Ability to independently perform Quality System (SOLTRAQS) documentation and SAP capabilities helpful 4: Excellent organizational skills, attention to detail, and strong oral and written communications skills 5. Independent decision making, triage and escalation of "at risk" projects

• What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? o Bachelor of Science; 4 year pharma, health care, or regulated industry
• What type of environment is this person working in? o Group setting o Individual Setting o Combination of both
• Work Schedule (Define days,# of hours)/ Is Overtime offered or required? If yes, how many hours, what impact to scheduled working hours? o 5 days/week Mon-Fri, 40 hours with flexibility on exact hours/day
• Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? o Combination of remote and in-person Lake County IL. 1-2 days on-site. 3-4 days remote
• Will there be Domestic and/or International Travel? If yes, list proposed countries and % of time travelling: o No travel required We also had drafted some roles/responsibilities for this position which I'm highlighting below in red.
• Follow the guideline (QCM01-01-001-G001) as the "Change Owner" and drive set-up and completion of the Change Plan for Product Life Cycle activity. (i.e. product discontinuations)
• Work with the Brand Manager to identify all critical information needed for the CP (timing, full scope, specific product information, name of the Supply Chain Planner, etc.

)

Note:

The Brand Manager is the true Change Owner and should be able to provide all critical information to the person who would be managing the CP portion.

• Set up Project Planning meetings, invite key areas listed in the guideline (and know who to contact for the meeting) o Brand manager to provide relevant contact details where needed.
• During the meeting(s) o Discuss the key topics listed in the guideline (scope, timing, impact to sites/affiliates.

...) o Request action items (information needed to populate the CP and tasks) from the core CFT and follow up if they do not provide the information (examples in Appendix A) o Go through the Potential task list with the team (Appendix B, C, or D as appropriate) to determine which tasks would be needed for the CP. o Request the team identify the main information for each task (Task Owner, Task Approver, Task due date)

• Populate the CP 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 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

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

Addition:

Manages/directs the activities and people associated with small to large scale projects with a focus on any or several non-IT business applications and disciplines. Manage/direct all facets of single or multiple, multidimensional, mission-critical projects through the Full Project Life Cycle. Collaborate/work with project sponsors, business units and users to identify project scope and focus, develop or monitor project initiatives, implement project requirements/plans/processes/tools, assign/guide/monitor project staff, and assure project success. Deliver quality project solutions to business problems or issues within defined budgets and/or timelines. Provide expert project guidance/support proactively through project completion. Provide tracking, reporting, and presentation to management and users. In addition, the role develops automation and improvement opportunities to the process and implements these opportunities; reports and shows improvement in metrics. 1-6 years' experience

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."