Operations Specialist I

By 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's Privacy Notice and Terms of Use.

I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the Role:As the Operations Specialist I, you will be responsible of managing investigations and Corrective/Preventive Actions (CAPA's) for manufacturing operations and accountable and accountable of closure investigational processes to support product release.The hours of this position are 8am to 5pm Monday through Friday; weekend and holiday work.

Overtime may be required.How you will Contribute:Lead Deviations/CAPA investigationsCollaborate with multiple teams (Quality, Engineering and Technical Service)Manage complex investigations using DMAIC toolsManage records workflow in Trackwise SystemAuthor Investigation ReportsStay current with biopharmaceutical industry best practices and technologies.Organize data and preparing appropriate documentation, including presentation materials, for assigned projectsYou will ensure implementation of corrective and preventive actionsAuthor 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 controlsYou will demonstrate continuous improvement concerning increasing job knowledge and proficiency related to the biopharmaceutical industry, and technical understanding/ capabilityWhat you bring to Takeda:Requires bachelor's degree in science, engineering or other related technical field.

Some related experience preferredProfessional (GMP industry) experience idealHave knowledge of core manufacturing principles and support systemsPrevious work in a team-based environment preferredHave experience using Excel (can maintain complex spreadsheets)Technical WritingWill manage multiple priorities or projectsImportant ConsiderationsAt 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 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.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.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.#GMSGQ #ZR1 #LI-OnsiteTakeda Compensation and Benefits SummaryWe 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:USA - GA - Social Circle - Hwy 278U.S.

Base Salary Range:$56,000.00 - $88,000.00The 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.

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

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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.

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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 StatementTakeda 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.LocationsUSA - GA - Social Circle - Hwy 278Worker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYes