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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 responsibility. 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:
- Produce 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 (KPI).
- Communicate with Trackwise 8 CCMS, Veeva, LIMS, and JDE for coordination of change control documents and status updates.
- Collaborate with 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, problem-solve and make sound assigned decisions (e.g. technical, compliance, and operations).
- Respond to customer and management questions and problems related to programs/policies.
- Understand business processes and responsibilities to identify opportunities for continuous improvement.
- Reduce the cost of non-value-added activities, implementing strategies to achieve department goals.
- Create and develop management tools, mechanisms for monitoring projects and important 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.
- Experience with critical manufacturing and facility processes/equipment.
- Understand scientific strategies and be able to create new processes or new avenues of Investigation.
- Experience in JDE, DeltaV, Trackwise 8, LIMS, Veeva or similar systems.
- Can understand and apply cGMP/GDP, follow CTP/SOPs, and meet EHS requirements.
What you bring to Takeda:
- Typically requires bachelor's degree in science, engineering, or another related technical field.
- 5+ years of related experience.
Important Considerations At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:
- May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Will need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
- May work in a cold, hot or wet environment.
- May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
- May manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Responsibilities 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.
More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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 Delivery
U.S. Base Salary Range: $67,900.00 - $106,700.00
The 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 e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . 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.
LocationsUSA - IL - Round Lake - Drug Delivery
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
