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Job Description

About the role:

The incumbent will provide Quality Assurance support for Manufacturing process / Critical utilities and providing Quality oversight and manufacturing support. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices. You will provide support to manufacturing using Electronic Batch Management (EBM) and guidance to other team members.   

The incumbent will be responsible to handle multiple projects, demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.  

How you will contribute:

Responsible ongoing, daily departmental Quality Assurance support for Manufacturing process / Critical utilities. Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude through collaboration with production supervisors, engineering, and other internal groups. 

Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.

Review electronic batch records, identify nonconformance’s and participate in investigation and Corrective and Prevention Action (CAPA) activities

Provide training and coaching to local employees and others as needed on relevant area(s). 

Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.

Oversee review and audit of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)

Participate in QA multi-site projects in the role of contributor, coordinator or lead.

Other duties, tasks or projects as assigned.

Must demonstrate critical thinking skills and understanding of the Manufacturing process and make Quality Decisions based on knowledge of regulations and regulatory trends.

Works closely with Manufacturing, Manufacturing compliance, QC laboratories and Technical Services to ensure meeting the requirement of quality and safety of Final product.  

What you bring to Takeda:

Typically requires Bachelors in Science / Business. In lieu of degree, 3+ years’ experience in Quality with a medical device/Pharma company or other similarly regulated industry.

Must be a team player with good problem solving, and good verbal and written communication skills.

Knowledge of TrackWise, Delta V and Electronic Batch Record Management preferred.

Key Skills, Abilities, and Competencies

Must be detailed oriented and have ability to multitask.

Must be able to maintain metrics and drive team and external partners to meet.

Metrics requirements.

Strong interpersonal/communication/influencing/negotiation skills and great attention to details are necessary.

Strong analytical and problem-solving skills.

Must have the ability to encourage teamwork and drive decisions.

Must be able to handle multiple projects concurrently.

Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint required.

Knowledge of Electronic Quality Systems (TrackWise), process control.

Systems (Delta V, BAS, PLC), Electronic Batch Record Management.

Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.  

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:

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.

Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

May work in a cold, hot or wet environment.

May work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

May work around chemicals such as alcohol, acids, buffers and Aerosol that may require respiratory protection.

May be required to work weekends, evenings, off-hours, and extended periods of time.

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

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-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.

LocationsUSA - GA - Social Circle - Hwy 278

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes