QC Specialist III - Microbiology - Expertise in Regulatory Compliance

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the Role :

Conduct advanced microbiological research and testing to support QC Micro projects. This role involves equipment qualification, partnership in the development of and validation of Microbiology methodologies, analyzing complex data, and ensuring compliance with regulatory standards. Self-led individual that works under only very general supervision to meet deadlines / goals .

How you will Contribute :

Identify and drive continuous improvement projects to improve quality, service, reliability, delivery, and / or cost by enhancing microbiological testing and laboratory operations.

Lead and provide project support for QC Microbiology, including microbiological assay validation, laboratory equipment qualification, and method improvement studies.

Understand operations / processes to provide technical support to troubleshoot and resolve issues related to microbiological assays, instruments, and equipment.

Author technical documents, protocols, and reports related to lab equipment qualifications, assay validations, and compliance-related studies as needed.

Maintain and compile QC Microbiology metrics including trend reports as needed (e.g., environmental monitoring).

Perform or review gap assessments for QC Microbiology to align with Global standards and regulatory requirements.

Maintain applicable QC Microbiology Standard Operating Procedures (SOP) to ensure compliance with FDA guidelines, QSR, cGMP, and other regulatory standards and drive procedural improvements.

Support internal and external audits (e.g., FDA, Corporate Quality Assessments) by ensuring compliance with procedures, guidelines, and regulatory requirements.

Serve as a subject matter expert and point of contact during inspections, providing responses to inquiries and demonstrating compliance with regulatory requirements.

Provide technical training and presentations to QC laboratory staff, including management, to ensure understanding of microbiological testing procedures and compliance.

Lead or actively contribute to team initiatives that enhance efficiency, cost savings, quality improvements, and problem-solving.

Proactively identify training needs, ensure personal training requirements are met, and maintain training records for laboratory personnel.

Stay current in the technical and compliance fields related to lab instruments, microbiological methods, and industry best practices.

May perform other duties as assigned.

What you bring to Takeda :

Typically requires bachelors' degree in science, engineering or other related technical field. 3+ years of related experience. Bachelor's Degree in Chemistry or Biological Science is preferred.

Strong knowledge of cGMP, QSR, USP, CFR, and other regulatory requirements.

Demonstrated working knowledge of microbiological assays, instrumentation, and equipment.

Ability to manage multiple priorities, meet deadlines, and maintain high-quality standards.

Strong organizational and problem-solving skills, with the ability to recommend and implement technical solutions.

Proficient in Microsoft Office (Word, Excel) and other relevant digital tools.

Detail-oriented, accountable, and committed to quality and compliance.

Skilled in decision-making to address technical, compliance, or operational issues; supports cross-functional problem-solving initiatives.

Solid understanding of laboratory, manufacturing, and facility processes.

Excellent verbal and written communication skills; able to collaborate effectively and train peers.

Working knowledge of applicable SOPs, EHS requirements, and cGMP / GDP standards.

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.

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 - CA - Los Angeles

U.S. Base Salary Range :

$86,500.00 - $135,960.00

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 - CA - Los Angeles

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes