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.
How you will contribute:
- Responsible for raw material and bulk container receipts, release and investigation if any issues are 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.
What you bring to Takeda:
- 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)
- Excellent influencing and negotiation skills.
- Acts as a change agent to sufficiently motivate team members to achieve team goals
- In general, the position requires a combination of sedentary work and walking around observing conditions of the facility.
- Must be able to carry up to 10lbs, lift up to 10lbs, push/pull up to 20lbs (with assistance of material handling equipment).
- Must be able to stand and/or walk for an extended period over an 8-12 hour shift between rooms and across the site.
- May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks
- Repetitive motions with hands, wrists, turning head, bending at knees and waist
- Typically requires, bachelors' degree in science, engineering, or other related technical field. Some related work experience preferred.
- Experience in pharmaceutical manufacturing of sterile drug and/or biologic solutions, preferred
- Some knowledge of applicable SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs
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:
- Indoor working conditions
- Will work around moving equipment and machinery
- May be required to work in controlled environments requiring special safety gear or gowning; will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, nail polish, or artificial fingernails may be worn in the manufacturing environment.
- May be required to work in confined spaces/areas.
- Must be able to work on day shift, including weekends and holidays, to support a 24/7 manufacturing operation as needed.
- Must be able to work non-traditional work hours or work extended hours, including weekends and holidays, as needed.
- 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.
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