About the role:
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Quality Assurance Specialist II in our state-of-the-art plasma fractionation facility in Social Circle, GA.
Here, everyone matters and you will be an important contributor to our inspiring, bold mission. As a QA Specialist II working on the Quality team, you will be empowered to perform document review and work with Manufacturing to support GMP compliance. You will report to the Supervisor, Quality Assurance.
This a 2nd Shift position. The hours of the position are 2 PM - 10:30 PM Monday - Friday.
How you will contribute:
- Provide Quality oversight and manufacturing support by Operations.
- Perform review of batch record documents on the shop floor.
- Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices.
- Provide manufacturing floor coverage and attend daily cross-functional departmental meetings.
- Identify nonconformance and participate in investigation and Corrective and Preventative Action (CAPA) activities.
- Use Quality Systems to assess product impact or review data.
- Author, review and approves written Standard Operating Procedures (SOPs) and submit procedural changes to meet requirements.
- Will spend a portion of time in clean room environment to provide oversight to manufacturing operations and will meet applicable gowning and personal protective equipment guidelines
- May work off-hours, and extended periods of time
- Training will occur on an alternate shift.
What you bring to Takeda
Bachelor's degree in Engineering, Science or related field or equivalent is preferred. 2+ years of experience required in the pharmaceutical or other similarly regulated industry.
- Must have the ability to participate in team activities with strong communication and negotiation skills
- Must be able to work independently and have initiative to complete tasks
- Must have analytical and problem solving skills
- Must have knowledge of and understand application of Good Manufacturing Practices
- Experience with Trackwise, EBM, and Delta V/PLC is preferred
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 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. 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 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.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.
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. Locations
USA - GA - Social Circle - Hwy 278 Worker Type
Employee Worker Sub-Type
Regular Time Type