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Job DescriptionAbout the role

• Leads ongoing, daily departmental operations.
• May include the guidance of assigned personnel in achieving defined quality goals
• Provide quality oversight for packaging operations, including control of printed materials, visual inspections, verification of labels and product packaging, perform AQL inspections.
• Review written Standard Operating Procedures (SOPs) and Job Aids (JAs)
• Support external assessments.
• Help with audits of reports (Protocols, Qualifications, Regulatory Submissions)
• Be a Subject Matter Expert (SME) and provide training to local employees on packaging compliance
• Other responsibilities, tasks, or projects as assigned

How you will contribute

• Must be able to make risk based decisions on deviations based on knowledge of regulations and regulatory trends.
• Must understand CFR requirements regarding packaging, label controls, and visual inspection.
• Work with manufacturing, engineering, and quality systems group as primary job responsibility.
• Required to send samples and communicate with interfacility labs.

What you bring to Takeda

• Associates degree in business/scientific discipline and one to three years of relevant experience .
• Bachelor's degree in the life sciences and experience with a medical device/pharma or other similarly regulated industry
• Experience with packaging operations in biopharmaceutical industry.

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,.
• 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.
#GMSGQ #ZR1
Takeda 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 278
U.S. Base Salary Range $56,000.00 - $88,000.00
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 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 278
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time