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Job Description

About the role:

As a Quality Control Analyst II, you will play a critical role in ensuring the safety, quality, and compliance of Takeda's life-changing therapies. In this role, you'll perform analytical testing, evaluate laboratory data, support quality systems, and help ensure manufacturing operations meet GMP, GLP, and regulatory requirements.

Working in a collaborative Quality Control environment, you'll utilize laboratory instrumentation, troubleshoot technical issues, support investigations, and partner with Manufacturing, Quality Assurance, Engineering, and other cross-functional teams to maintain operational excellence. Depending on business needs, this role may support QC Analytical, Microbiology, Compliance, QCMIS, or Laboratory Operations, providing opportunities to develop expertise across multiple Quality functions. Your work will directly contribute to delivering safe, high-quality therapies to patients around the world.

How you will contribute:

• Perform analytical testing using established laboratory methods and techniques, including High-Performance Liquid Chromatography (HPLC) and other analytical instrumentation, while ensuring accurate, timely, and compliant results.

• Analyze laboratory data, prepare technical documentation and reports, and maintain accurate records using Laboratory Information Management Systems (LIMS) and other laboratory software.

• Troubleshoot laboratory equipment, analytical methods, and testing issues, escalating complex problems when appropriate and supporting timely resolution.

• Support laboratory investigations, auditing activities, Corrective and Preventive Actions (CAPAs), and continuous improvement initiatives to strengthen quality and compliance.

• Maintain laboratory equipment, perform routine maintenance activities, and ensure instrumentation remains qualified and operational.

• Adhere to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), safety requirements, and applicable regulatory guidelines while promoting a culture of quality and compliance.

• Collaborate with Manufacturing, Quality Assurance, Engineering, and other cross-functional partners to communicate testing status, resolve issues, and support production timelines.

• Assist with method implementation, laboratory documentation, and quality control processes while supporting operational excellence across laboratory functions.

• Participate in training activities, share technical knowledge with team members, and support additional laboratory responsibilities as assigned.

What you bring to Takeda:

• ​Typically requires a Bachelor's degree in Chemistry, Biology, Biochemistry, Microbiology, Engineering, or another related scientific discipline

• Minimum of 3+ years of laboratory, quality control, or analytical testing experience in a pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment required.

• Experience performing analytical testing using wet chemistry, biochemical methods, High-Performance Liquid Chromatography (HPLC), and other laboratory instrumentation required.

• Working knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), laboratory safety requirements, and applicable regulatory standards required.

• Experience using Laboratory Information Management Systems (LIMS) or similar laboratory software, with proficiency in laboratory documentation, data analysis, technical report writing, and interpretation of analytical results required.

• Strong technical troubleshooting, analytical problem-solving, and organizational skills, with the ability to manage multiple priorities while maintaining accuracy, compliance, and attention to detail required.

• Experience operating, maintaining, and troubleshooting laboratory instrumentation and equipment, including analytical equipment, incubators, autoclaves, or similar laboratory systems required.

• Excellent verbal and written communication skills, with the ability to collaborate effectively across Manufacturing, Quality Assurance, Engineering, and other cross-functional teams required.

• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint required.

• Experience supporting laboratory investigations, audits, Corrective and Preventive Actions (CAPAs), quality system processes, or continuous improvement initiatives preferred.

• Demonstrated ability to train, mentor, or provide technical guidance to colleagues and serve as a technical resource within the laboratory preferred

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:

• Indoor working conditions

• Will work around moving equipment and machinery

• May be required to work in controlled environments requiring special safety gear or gowning; will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, nail polish, or artificial fingernails may be worn in the manufacturing environment.

• May be required to work in confined spaces/areas.

• Some Clean Room and/or cool/hot storage conditions.

• May be exposed to and must not be allergic to cephalosporin.

• Must be able to work non-traditional work hours, including weekends and holidays, as needed.

• Must be able to work overtime as required.

• Must be able to speak, read, write, and follow detailed written and oral instructions in English

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-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:

$71,800.00 - $112,860.00

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.

Locations

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes