Job Description

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Job Description

About the role:

As an Operations Specialist I, you will be responsible of managing investigations and Corrective/Preventive Actions (CAPA's) for manufacturing operations and accountable of closure investigational processes to support product release. Typical working hours: 8am to 5pm Monday through Friday. Additional working hours may be required as needed. You will report to a Manufacturing Systems Compliance Lead at our Social Circle, GA manufacturing facility.

How you will contribute:

• Lead Deviations/CAPA investigations
• Collaborate with multiple cross functional teams (Quality, Engineering and Technical Service)
• 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

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 wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• 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, 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 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.

#GMSGQ

#ZR1

#LI-Onsite

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:

U.S. Base Salary Range:

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 employees may be eligible for short-term and/ or long-term incentives. 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.

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