Quality Assurance Specialist II – Engineering Support - Takeda

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Job Description

About the role:

Providing support for Critical utilities and Quality oversight over Engineering functions (Meteorology/ Maintenance), you will identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines, and Takeda quality practices. You will handle projects, demonstrate effectiveness in task completion, empowerment of others, exception management, training, problem solving and team leadership.This is a full-time opportunity reporting to the Director, Quality Assurance Plasma OpU Quality at our Social Circle, GA facility.

How you will contribute:

• Review, analyze and revise written Standard Operating Procedures (SOPs), Job Aids, Work instructions and submit procedural changes to meet Corporate, Divisional, Plant, and Regulatory Requirements.
• Oversee review of multiple reports (Protocols, Qualifications, Regulatory Submissions)
• Provide quality representation in EAC meetings; Ensure the triages occurring in the CUB are responded to and completed in a compliant manner along with BAS Alarm review.
• Ensure change control and TW deviations for the area of responsibilities are initiated and closed; Conduct gap analysis of site procedures with global documents and rectify related to Critical utilities and Engineering documents.
• Navigate through Trackwise and LabWare for deviations, CAPA’s Change Controls and lab results; Support internal/external inspection regarding BAS alarms, Pest Control, Metrology Deviations.
• Support reviewing and approval of Triages coming out of CUB control room and provide audit readiness and provide necessary coaching and GMP training.

What you bring to Takeda:

Education and Experience Requirements

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

Key Skills, Abilities, and Competencies

• An understanding of microbiology and contamination control.
• Analytical and problem-solving skills and willing to participate in rDMAIC.
• Knowledge of Microsoft Word, Excel and PowerPoint, and Electronic Quality Systems (Trackwise), LabWare, RAM, JDE
• Knowledge of FDA Regulations, Application of GLP, and Application of GMP.

Complexity and Problem Solving

• Knowledge of Engineering processes, specifically, water systems, RO Systems and Alcohol distillation along with Metrology concepts.

Other Job Requirements

• Work multiple shifts including off hours, weekends, or be asked to work supplemental hours. Work around chemicals such as alcohol, acids, buffers and Aerosil that may require respiratory protection.
• May work weekends, evenings, off-hours, and extended periods of time.

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:

• 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 artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• 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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#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:

$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