QC Analyst II

Regulatory Toolkit; Thousand Oaks (CA); Presencial; USD 44.000 - 69.000; Jornada completa

Descripción de la vacante

Takeda in Thousand Oaks, CA is seeking a Quality Control Analyst II to manage analytical testing, perform analyses on raw materials, in-process and final products, and ensure data integrity throughout testing and documentation. You will collaborate with quality partners and leadership to maintain compliant laboratory operations.

You will review records, support investigations, and mentor less experienced analysts while adhering to FDA and GMP requirements.

Formación

• High school diploma or equivalent is required.
• At least three years of relevant laboratory or quality-control experience.
• Understanding of analytical methods, critical controls, expected assay behavior, and how sample handling can affect results.
• Ability to independently perform and assess routine and moderately complex laboratory analyses and recognize unusual patterns.

Responsabilidades

• Manage assigned analytical testing from sample prep to handoff for review.
• Perform laboratory analyses of materials and products using approved methods and equipment.
• Assess controls, instruments, and results during testing to identify issues.
• Troubleshoot routine and moderately complex issues with methods and instruments; escalate when needed.
• Maintain and review testing records for accuracy, traceability, and compliance.
• Support investigations and improvements by reporting atypical results and preserving records.
• Coordinate readiness and coach analysts on methods and documentation.

Conocimientos

Analytical testing

Laboratory analysis

Quality systems

Data review

Troubleshooting

Documentation

Mentoring

Collaboration

Educación

High school diploma or equivalent

Herramientas

Microsoft Office

Laboratory data systems

Descripción del empleo

Job Description

About the Role:

As a Quality Control Analyst II, you will help maintain reliable laboratory operations and support the quality of manufacturing samples and products. You will independently manage assigned analytical work, applying your understanding of assay principles, instrument performance, laboratory controls, and quality systems to produce accurate, well-documented results. You will be part of the Analytical Quality Control team in Thousand Oaks, working with analysts, quality partners, technical support, and laboratory leadership. Your sound scientific judgment will help identify unexpected results, address routine and moderately complex issues, and support evidence-based investigations. You will also help less experienced analysts build their skills in established methods and documentation. By balancing testing priorities and escalating complex decisions appropriately, your work will contribute to dependable laboratory outcomes and team goals.

How You Will Contribute:

• Manage assigned analytical testing from sample and method readiness through execution, calculations, documentation, and timely handoff for review.
• Perform laboratory analyses of raw materials, in-process and final products, environmental-monitoring samples, and other manufacturing samples using approved methods and qualified equipment.
• Assess controls, instruments, and results during testing to identify potential execution or equipment issues and results that may need quality-system evaluation.
• Troubleshoot routine and moderately complex issues with methods and instruments, document actions and impacts, and **escalate issues beyond your authority.
• Maintain and review testing records for accuracy, traceability, calculations, method adherence, and compliance, and complete authorized data reviews and system transactions.
• Support quality investigations and laboratory improvements by reporting atypical results promptly, preserving relevant records and samples, and collaborating on evidence-based assessments and practical improvements.
• Coordinate laboratory readiness and coach analysts by addressing equipment, supply, and scheduling constraints and supporting less experienced colleagues on established methods and documentation.

Qualifications:

• High school diploma or equivalent.
• At least three years of relevant laboratory or quality-control experience.
• Practical understanding of analytical methods, critical controls, expected assay behavior, and how sample handling or preparation can affect results.
• Ability to independently perform and assess routine and moderately complex laboratory analyses and recognize unexpected control, instrument, or result patterns.
• Working knowledge of applicable FDA and GMP requirements, Good Documentation Practices, data integrity, standard operating procedures, and laboratory quality systems.
• Ability to review testing records, conduct authorized data review and laboratory data system transactions, and support investigations within assigned authority.
• Ability to plan and prioritize concurrent testing, communicate technical issues clearly, and collaborate with analysts, quality partners, technical support, and laboratory leadership.
• Proficiency with laboratory data systems and Microsoft Office applications for documenting, reviewing, and communicating assigned work.

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:

• 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/or 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, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• The overall physical exertion of this position requires light to medium work.
• May be required to sit between 3-4 hours, walk between 1-2 hours and stand for over 4 hours
• May be required to bend at the neck/waist, squat and climb (using step stools and ladders) between 1-2 hours
• May be required to reach above/below the shoulder, kneel, twist at the neck/waist between 1-2 hours

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 - CA - Thousand Oaks - Rancho Conejo

U.S. Hourly Wage Range:

$31.88 - $50.08

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

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 - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No