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Quality Assurance Specialist I

2 months ago

Social Circle, United States Takeda Pharmaceutical Full time

**About the role**:
As a Quality Insurance Specialist I, you will provide Quality Assurance support for Manufacturing process, Important utilities, provide 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. You will be responsible for multiple projects, demonstrate effectiveness in task completion, empowerment of others, exception management, training, problem solving and team leadership.

**How you will contribute**:

- Responsible for inspection and release of production materials, components, and chemicals to the Manufacturing facility.
- Perform material holds of non-conforming material.
- Support warehouse and be able to provide guidance for Warehouse operations regarding incoming receipt quality issues and alarm reviews.
- Ensure the laboratory area is maintained in a GMP state while following all EHS guidelines.
- Support execution of validations for lab equipment, Lab methods and facility projects.
- Maintain Data integrity and ensure compliance with company SOPs, specifications, FDA, cGLP and cGMP regulations.
- Promote continuous improvements through participation in the Quality Improvement Program. Create/Revise material specifications by conducting analysis of written procedures and submit procedural changes to meet corporate, divisional and regulatory requirements.

**What you bring to Takeda**:

- Typically requires Associate's degree in business/scientific discipline and 3+ years of relevant experience or Bachelor's degree required.

**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 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.
- Will operate a forklift, electronic/manual pallet jack within a warehouse environment. Will carry up and lift up to 50 lbs., and push/pull > 100 lbs. with pallet jack, upon training completion.
- May work in cold room environments.
- May require bending, twisting, reaching overhead, and squatting motions to perform certain tasks.

**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-MA1

LI-Onsite

**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**:
$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 eligib

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