Takeda Pharmaceutical
QC Specialist III - Microbiology
Takeda Pharmaceutical, Los Angeles, California, United States
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
Takeda’s
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.
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
e
mployee
s
may be eligible for
s
hort
-
t
erm and/
or
l
ong-
t
erm
incentive
s
.
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
the information I provide in my application will be processed in line with
Takeda’s
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.
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
e
mployee
s
may be eligible for
s
hort
-
t
erm and/
or
l
ong-
t
erm
incentive
s
.
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