About the role:
The primary responsibility is working on Materials release and approval of completed documentation for batch folders for GMP/GDP. In addition, the incumbent is accountable for Quality oversight on the floor and trending of observations from floor to improve them continuously. The incumbent is responsible for manufacturing support activities on the floor, revising SOPs and forms, and developing training.
- Responsible for raw material and bulk container receipts, release and investigation if any issues found. Follow-up with appropriate Takeda facilities for documentation correction in timely manner.
- Manufacturing support activities including batch record documentation, issuance of Batch record, approval of OSI PI Reports, scanner card management, management and delivery of test and stability samples, label copy control and issuance, raw material release, in-process work order release, and retain sample management.
- Responsible for oversight of quality line operations in terms of product quality and conformance to regulations and Takeda quality policies and procedures.
- Identifies and assesses quality risk in production operations daily. TIQ/QOTSF review of checklists and trending of observations for monthly quality council. TIQ/QOTSF program management.
- Development of training materials and procedures and participation on cross-functional teams to identify and implement process improvements. Serve as Subject Matter Expert (SME) and provide training to employees needed on relevant areas.
- Ability to handle multiple projects. Demonstrates effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, and problem solving
- Complete interfacility impact assessments for product/process changes.
- Responsible for owning root cause investigations, close deviations, assignment of proper corrective actions, and facilitate implementation for Manufacturing under the direction of Compliance Management.
How you will contribute:
Typically requires, bachelors' degree in science, engineering, or other related technical field. Some related experience preferred.
Aseptic Manufacturing experience (preferably with a strong focus on fill/finish operations) preferred
What you bring to Takeda:
Must be able to work second shift.
Must be able to work nights, weekends, and holidays to support manufacturing when needed.
Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)
Knowledge of the local and international regulatory environment and regulations for manufacture of biological products.
Strong analytical and problem-solving skills.
Excellent verbal and written communication skills in English.
Adaptive communication and presentation skills to effectively reach different levels, including senior management.
Skilled in Microsoft Office 365 applications (Teams, Excel, PowerPoint, Word, Visio SharePoint)
Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
Excellent influencing and negotiation skills.
Acts as a change agent to sufficiently motivate team members to achieve team goals.
Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
Should be familiar with Quality Risk Management principles.
Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products.
Must be able to deal with ambiguity and make decisions under stressful conditions. Ability to understand complex problems and anticipate consequences of actions/decisions made.
Must be able to work in controlled/classified environments requiring special gowning.
Required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
Deals with plasma finished products; transfer of intermediates and products between sites/countries.
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement
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. In this role, you 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.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
- Ability to walk 1-3 miles, stand for extended periods of time and lift 10 lbs. during a workday as required.
- Ability to be sedentary for an extended period of time.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will 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.
This posting excludes Colorado applicants.
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.
USA - IL - Round Lake - Drug Delivery