Operations Specialist I

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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.

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