Operations Specialist
応募後で応募 求人ID R0104495 掲載日 08/28/2023 Location:Social Circle, GeorgiaBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role:
The Operations Specialist reports to the Investigations Supervisor. You will be responsible of managing investigations and Corrective/Preventive Actions (CAPA's) for manufacturing operations and accountable of timely closure investigational processes to support product release. Typical working hours: 8am to 5pm Monday through Friday. Additional working hours may be required as needed.
How you will contribute:
Lead Deviations/CAPA investigations
Collaborate with multiple cross functional teams (Quality, Engineering and Technical Service, etc.)
Manage complex investigations using DMAIC tools
Manage records workflow in Trackwise System
Author Investigation Reports
Stay current with biopharmaceutical industry best practices and technologies.
Organize data and preparing appropriate documentation, including presentation materials, for assigned projects
You will ensure implementation of corrective and preventive actions
Author and revise GMP documents and manufacturing records (e.g. Batch records, SOPs, change controls)
Implement improvement programs to improve yield, and process robustness. This may require leading and implementing change controls
You will demonstrate continuous improvement concerning increasing job knowledge and proficiency related to the biopharmaceutical industry, and technical understanding/ capability
What you bring to Takeda:
Typically requires bachelor's degree in science, engineering or other related technical field. Some related experience preferred
Professional (GMP industry) experience ideal
Have knowledge of core manufacturing principles and support systems
Previous work in a team-based environment preferred
Have experience using Excel (can maintain complex spreadsheets)
Strong Technical Writing
Ability to manage multiple priorities
You may occasionally work in a clean-room environment and wear special garments
You may occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) because of safety requirements in specific areas. Company provides PPE.
You maybe asked to work off-hours, extended periods of time occasionally
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
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. 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.
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.
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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.