Operational Specialist II, IG Visual Inspection and Packaging - Takeda

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Job Description

About the role:

You will help develop a plasma processing facility to bring us additional capacity for fractionation, purification, and fill and finish for its biologic medications. You will report to a Senior Continuous Excellence Manager in Social Circle, GA.

How you will contribute:

• Guide manufacturing deliverables to ensure successful commercial operations.
• Author and revise GMP documents and manufacturing records (e.g. SOPs, Job Aids)
• Train staff in general manufacturing activities.
• Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks.
• Implement improvement programs to improve yield, reliability, and process robustness. This may require leading and implementing change controls.
• Demonstrate continuous improvement concerning increasing job knowledge and proficiency related to the biopharmaceutical industry, and technical understanding/problem solving capability
• Stay current with biopharmaceutical industry best practices and technologies.
• Organize data and preparing appropriate documentation including presentation materials for assigned projects.
• Lead any CAPA investigations: Lead problem solving and root-cause analysis sessions: Work with Quality, Engineering and Tech Service units; Manage complex investigations using DMAIC tools Ensure implementation of corrective and preventive actions
• Change Controls (CC) main contact for multiple manufacturing units, including:
• Multiple CCs Owner in Track-wise system (e.g. materials, process, equipment, IT systems)
• Project manage CCs implementation
• Ensure appropriate CC assessments are completed
• Coordinate CC implementation with necessary teams
• Ensure staff is trained on changes
• Ensure documentation quality and regulatory compliance

What You Bring to Takeda:

• Requires bachelor's degree in science, engineering or other related technical field. 2+ years of related experience.
• Minimum two years relevant professional (GMP industry) experience required.
• Have knowledge of core manufacturing principles and support systems.
• Communicate with teams and management on recommended course of action.
• Experience using Word, Excel and PowerPoint.
• Prefer experience in Track-wise system.
• Prefer experience in Automation Control Systems, EBM (Electronic batch Record), PI Historian.
• Prefer knowledge of Lean Six-Sigma methodology.

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:

• 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.

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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:

USA - GA - Social Circle - Hwy 278

U.S. Base Salary Range:

$67,900.00 - $106,700.00

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-termincentives. 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.

Locations

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time