![Orion Group](https://media.trabajo.org/img/noimg.jpg)
Change Control Specialist
3 weeks ago
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 (QCM 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 QCM with specific examples and guidance from QCM 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.
-
Automation Specialist
6 days ago
Waukegan, Illinois, United States Spectraforce Technologies Full timeTitle: Automation SpecialistLocation: Lake County, ILDuration: 12 month ( possible extension)Job DescriptionApply multi-disciplinary skills in engineering, controls and computer programming to design, build, and program a collection of laboratory equipment in custom enclosures to enable a complete custom automated platform for smart chemical process...
-
QA Specialist
6 days ago
Waukegan, Illinois, United States Spectraforce Technologies Full time:Title - QA SpecialistDuration 6 MonthsLocation - Waukegan, IL HybridDetailsWork with Databases and electronic systems. Follow through with remediation action owner to ensure timely completion of activities. Keep dashboards up to date with relevant information.Skills:Change Management. Organization & follow-up with existing recordsEducation: 4+ years of...
-
Multimedia Specialist
6 days ago
Waukegan, Illinois, United States TEKsystems Full timeMultimedia Specialist / Video Producer Hybrid 2-4 time a month depending on content schedule Waukegan, IL 40 hours a week 12 month contract CST Hours Must have portfolio/ Reel Demo 1 Step interview process This Multimedia specialist / video producer will be supporting a learning and development team. It is important this person be...
-
Culture and Climate Specialist
6 days ago
Waukegan, Illinois, United States Waukegan Community Unit District 60 Full timePosition Type: Administration Level 2/Dean Date Posted: 5/16/2024 Location: Carman-Buckner Elementary School Closing Date: 06/28/2024 Who We Are: Waukegan Community Unit School District No. 60 serves nearly 15,500 students in preschool through grade 12 and is located halfway between Chicago, Illinois and Milwaukee, Wisconsin on the shores of Lake Michigan....
-
Waukegan, Illinois, United States Illinois Department of Human Services Full timeThis job was posted by : For more information, please see: Location:Waukegan, IL, US, Job Requisition ID:[38753]{lang="en-US" careersite-propertyid="customfield2"}DCFS is deeply committed to the welfare and protection of children. Our goal is to protect children by strengthening and supporting families. In every effort, from receiving hotline calls to...
-
Technical Specialist
6 days ago
Waukegan, Illinois, United States eTeam Full timeJob Description Backup Administrator (L3) is an individual contributor role and will be responsible to provide level 3 operations support to our clients Storage and Backup environments. Additional responsibilities include training and mentoring junior members of the operations team. Main Duties: Administer, maintain, upgrade, troubleshoot, and support...
-
QA Specialist II
4 weeks ago
Waukegan, Illinois, United States Randstad USA Full timejob summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A...
-
QA Specialist II
6 days ago
Waukegan, Illinois, United States Randstad USA Full timejob summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A...
-
Waukegan, Illinois, United States Lake Behavioral Hospital Full timeLake Behavioral Hospital is seeking a Registered Nurse (RN) Utilization Review for a nursing job in Waukegan, Illinois.Job Description & RequirementsSpecialty: Utilization ReviewDiscipline: RNDuration: Ongoing40 hours per weekShift: 8 hours, daysEmployment Type: StaffJob DetailsJob LocationLake Behavioral Hospital - Waukegan, ILPosition TypeFull TimeJob...
-
Advanced Practice Nurse
6 days ago
Waukegan, Illinois, United States Transitions Group Full timeOur people are the difference.Transitions Care is a leading hospice organization that has changed the hospice experience for patients, families, and team members. Imagine a healthcare company that provides 24/7 access to services in the comfort of the patient's home - providing the physical, emotional, and spiritual support that allows a patient to focus on...
-
Call Center Representative
6 days ago
Waukegan, Illinois, United States TEKsystems Full time*Description:* Rotating 8 hour Shifts between 7am 5:30pm. Candidates must be available to work as early as 7am and as late as 5:30pm. No exceptions. High volume call center, taking inbound calls/orders a day in a call center environment Entering in high volume orders depending on the dealer calling in 60% of calls will result in an order, 40% will be...
-
Substitute Safety Officer
6 days ago
Waukegan, Illinois, United States Waukegan Public School District 60 Full timePosition Type:SecurityDate Posted:11/3/2023Location:All schools in the DistrictClosing Date:until filledAdditional Information:Show/HideWho We Are:Waukegan Community Unit School District No. 60 serves nearly 15,500 students in preschool through grade 12 and is located halfway between Chicago, Illinois and Milwaukee, Wisconsin on the shores of Lake Michigan....
-
Insurance Underwriter E&O
6 days ago
Waukegan, Illinois, United States Diedre Moire Full timeDirectors & Officers Liability Insurance Underwriter - Waukegan,IL Seeking individual with background underwriting new and renewal business focused on Directors & Officers Liability risks to join a company and make a lasting impact through growth of a profitable book of businessActivities:Evaluate applications and determine terms, rates, and plans based on...
-
Housing Choice Voucher Case Manager I
6 days ago
Waukegan, Illinois, United States Waukegan Housing Authority Full timeJob DescriptionJob DescriptionUnder the direction of the HCV Supervisor, the HCV Case Manager I is responsible for assisting clients and evaluating their continued eligibility for housing assistance. This position ensures that clients understand the requirements of the Housing Choice Voucher (HCV) program in accordance with the Housing Authority's...
-
Insurance Underwriter E&O
6 days ago
Waukegan, Illinois, United States Diedre Moire Full timeDirectors & Officers Liability Insurance Underwriter - Waukegan,IL Find out more about this role by reading the information below, then apply to be considered. Seeking individual with background underwriting new and renewal business focused on Directors & Officers Liability risks to join a company and make a lasting impact through growth of a profitable book...
-
Change Control Specialist
3 weeks ago
Waukegan, United States Orion Group Full timeLocation: Waukegan, IL Contract Length: 12 Months Pay Rate: $33-38/hr including individual healthcare coverage Job DescriptionOrion 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...
-
Change Control Specialist
2 weeks ago
Waukegan, United States Orion Engineering, Inc. Full timeJob 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...
-
Change Control Specialist
1 week ago
Waukegan, United States Orion Group Full timeLocation: Waukegan, ILContract Length: 12 MonthsPay Rate: $33-38/hr including individual healthcare coverageJob DescriptionOrion 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...
-
Quality Specialist
2 months ago
Waukegan, United States Thermoflex Corporation Full timeJob DescriptionJob DescriptionSalary: Position Title: Quality Specialist Reports To: Quality Engineering ManagerDepartment: Manufacturing Direct Reports (if applicable): N/A2nd Shift - 2:55pm - 11:10pm SummaryThe...
-
Quality Specialist
3 weeks ago
Waukegan, United States Thermoflex Corporation Full timeJob DescriptionJob DescriptionSalary: Position Title: Quality Specialist Reports To: Quality Engineering ManagerDepartment: Manufacturing Direct Reports (if applicable): N/A2nd Shift - 2:55pm - 11:10pm SummaryThe...
-
Regulatory Affairs Specialist
4 weeks ago
Waukegan, United States Onward Technologies Inc. Full timeTitle: Regulatory Affairs Specialist Location: Waukegan, IL Position Summary: A Regulatory Affairs Specialist who can handle Regulatory requirements related to EUMDR for a Software as a Medical Device (SaMD). Primary Duties: Perform gap analysis to understand the currents gaps in regulatory documentation with respect to EUMDR. Assess acceptability and...
-
Automation Specialist
4 weeks ago
Waukegan, United States Spectraforce Technologies Full timeTitle: Automation Specialist Location: Lake County, IL Duration: 12 month ( possible extension) Job Description Apply multi-disciplinary skills in engineering, controls and computer programming to design, build, and program a collection of laboratory equipment in custom enclosures to enable a complete custom automated platform for smart chemical process...
-
Quality Specialist
2 months ago
Waukegan, United States Thermoflex Corporation Full timeJob DescriptionJob DescriptionSalary: Position Title: Quality Specialist Reports To: Quality Engineering ManagerDepartment: Manufacturing Direct Reports (if applicable): N/A2nd Shift - 2:55pm - 11:10pm SummaryThe...
-
Quality Specialist
3 weeks ago
Waukegan, United States Thermoflex Corporation Full timeJob DescriptionJob DescriptionSalary: Position Title: Quality Specialist Reports To: Quality Engineering ManagerDepartment: Manufacturing Direct Reports (if applicable): N/A2nd Shift - 2:55pm - 11:10pm SummaryThe...
-
Quality Specialist
2 weeks ago
Waukegan, United States Access Pharmaceutical Full time**Description**: Job Title - Quality Specialist Job Location: Waukegan, IL Job ID - 1QSIL **Quality Specialist**: **AREAS OF RESPONSIBILITY** - Collaborate with various levels of management, cross-functional teams, and external stakeholders - Highly organized with the ability to manage, track and escalate (as needed) multiple tasks and activities -...
-
Curriculum Specialist
2 months ago
Waukegan, United States Boys & Girls Club of Lake County Full time**Boys & Girls Club of Lake County - Curriculum Specialist** The Boys and Girls Clubs of Lake County seeks a highly motivated and innovative Curriculum Specialist to plan, implement, supervise, and evaluate all curricula provided in program areas, focusing on achieving priority outcomes of Academic Success, Good Character and Citizenship, and Healthy...
-
Interim Controller
3 weeks ago
Waukegan, United States Brilliant Management Resources - IL Full timeJob DescriptionJob DescriptionA healthcare client of ours (near Waukegan, IL) is seeking an Interim Controller to join their team (1-2 month contract). Must have prior Controller experience in Healthcare IndustryResponsible for the leadership and oversight for the accounting, finance, budget and reimbursement functions managing the day-to-day accounting...
-
Quality Control Lab Supervisor
2 weeks ago
Waukegan, United States The Visual Pak Companies Full time**Position Title**:Quality Control Lab Supervisor **Reporting into Title**:Quality Control Manager **Direct Reports** - 1-10 reports including Chemists and Quality Control Associates. **Position Responsibilities-Tasks-Deliverables** All duties as assigned and the following specific activities. - Accountable for all quality control department shift...
-
Recovery Support Specialist
4 weeks ago
Waukegan, United States Independence Center Full timeJob Type Full-time, Part-time Description All shifts available. We are a 24 hour seven day a week program. Full-time and part-time positions are available. Full time includes benefits. Must be an adult who has previously utilized mental health or substance-use services, is currently in recovery, and is excited to model recovery for others experiencing...
-
Recovery Support Specialist
4 weeks ago
Waukegan, United States Independence Center Full timeJob Type Full-time, Part-time Description All shifts available. We are a 24 hour seven day a week program. Full-time and part-time positions are available. Full time includes benefits. Must be an adult who has previously utilized mental health or substance-use services, is currently in recovery, and is excited to model recovery for others experiencing...
-
Recovery Support Specialist
4 weeks ago
Waukegan, United States The Independence Center Full timeJob DescriptionJob DescriptionDescription: All shifts available. We are a 24 hour seven day a week program.Full-time and part-time positions are available. Full time includes benefits. Must be an adult who has previously utilized mental health or substance-use services, is currently in recovery, and is excited to model recovery for others experiencing...
-
Recovery Support Specialist
4 weeks ago
Waukegan, United States The Independence Center Full timeJob DescriptionJob DescriptionDescription: All shifts available. We are a 24 hour seven day a week program.Full-time and part-time positions are available. Full time includes benefits. Must be an adult who has previously utilized mental health or substance-use services, is currently in recovery, and is excited to model recovery for others experiencing...
-
Recovery Support Specialist
4 weeks ago
Waukegan, United States The Independence Center Full timeJob Description Job Description Description: All shifts available. We are a 24 hour seven day a week program. Full-time and part-time positions are available. Full time includes benefits. Must be an adult who has previously utilized mental health or substance-use services, is currently in recovery, and is excited to model recovery for others experiencing...
-
Recovery Support Specialist
3 weeks ago
Waukegan, United States The Independence Center Full timeJob Description Job Description Description: All shifts available. We are a 24 hour seven day a week program. Full-time and part-time positions are available. Full time includes benefits. Must be an adult who has previously utilized mental health or substance-use services, is currently in recovery, and is excited to model recovery for others experiencing...
-
Order Processing
4 weeks ago
Waukegan, United States Thermoflex Corporation Full timeJob DescriptionJob DescriptionSalary: Position Title: Order Processing & Logistics Specialist Reports To: Logistics ManagerDepartment: Supply Chain & Logistics Direct Reports (if applicable): N/A SummaryFast-growing manufacturing company serving the automotive industry is seeking...