Change Control Specialist
Round Lake Beach, IllinoisOn the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
- Small Molecules
- Biologics
- Plasma
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
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Job Description
About the role
The Change Control Specialist serves as a Subject Matter Expert (SME) and Owner in the performance/management of Quality Systems Change Control. As the change control specialist, you will prepare change control documents and coordinating change control activities from initiation through completion/implementation as defined in the change control requirements. You will also be the primary individual performing status update of changes in Trackwise 8 CCMS and JDE; and closure of change control documents. This position shall also serve as Digital Document Management Coordinator and Subject Matter Expert (SME) in Takada document format guidelines. Provide advanced GMP and analytical support to the Manufacturing operations team. Direct interactions with contractors, vendors, suppliers and customers may also be necessary. You will report to the Associate Director of Manufacturing Support
How you will contribute
- Generate change control documents for manufacturing and maintenance PM's and corrective maintenance.
- Manage content and closure of Level 1 and Level 2 changes including the assignment of actions/tasks to manufacturing and other support responsibilities.
- Manage performance of change control as measured by the measurements.
- Interface with Trackwise 8 CCMS, Veeva, LIMS, and JDE for coordination of change control documents and status updates.
- Collaborate with cross functional teams during change control review boards, QIT's, planning meetings to achieve quality and compliance goals, representing manufacturing change control team.
- Create technical reports by compiling technical information as defined by the change control requirements
- Perform documentation/formatting changes (SOP's, batch records, PM's, BOM's, product specifications) or create new documents.
- Coordinate periodic review of manufacturing related documents.
- Participate in critical safety and continuous improvement related activities in the site.
- Lead teams, encourage teamwork, and make sound assigned decisions ((e.g. technical, compliance, and operations).
- Respond to customer and management questions and problems related to projects/policies, etc.
- Analyze business processes and responsibilities to identify opportunities for continuous improvement.
- Reduce the cost of non-value-added activities and developing strategies to achieve department goals.
- Create and develop management tools, mechanisms for monitoring projects and main matrices.
- Maintain data integrity and ensure compliance with company SOP's and specifications, FDA, GLP. CSR and cGMP regulations investigate deviations and write exception documents.
- Perform other support activities for production needs.
What you bring to Takeda
- Typically requires bachelor's degree in science, engineering, or another related technical field.
- 5+ years of related experience; some leadership experience.
- Understanding of critical manufacturing and facility processes/equipment.
- Understand scientific strategies and be able to create new processes or new avenues of Investigation.
- Have a high reading comprehension skill. Can communicate and Interpret data..
- Experience in JDE, DeltaV, Trackwise 8, LIMS, Veeva or similar systems.
- Apply logic-based decision-making to technical, compliance, or operational problems as assigned.
- Motivate people, encourage teamwork, teach investigational techniques, and assist Manager in driving team objectives.
- Will understand and apply cGMP/GDP, follow CTP/SOPs, and meet EHS requirements.
- Demonstrate knowledge of Quality systems.
Important Considerations
- The physical exertion of this position is sedentary work.
- May need to work in controlled or clean room environments requiring special gowning. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in this work
- May manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling and on-site transporting of hazardous wastes.
- Although assignments will be made specific to working hours, flexibility is expected, with the understanding that process validation and production objectives may necessitate changes in work hours and responsibilities.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - IL - Round Lake - Drug DeliveryU.S. Base Salary Range:
$67,900.00 - $106,700.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
USA - IL - Round Lake - Drug DeliveryWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWorking at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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