QC Analyst II - cGMP Lab & Investigations

Takeda; Brooklyn Park (MN); On-site; USD 70,948,000 - 111,379,000; Full time

Job summary

Takeda is seeking a Quality Control Analyst II in Brooklyn Park, MN to execute and review routine sampling and test methods across in-process, drug substance, and stability programs. You will work with LIMS, Endoscan, and MODA systems to collect data and ensure data integrity within cGMP guidelines.

This role requires 3–6 years in a regulated lab, strong instrumentation knowledge, and the ability to communicate effectively in English.

Qualifications

• Bachelor’s or master’s degree in Life Sciences with relevant lab coursework.
• 3-6 years of relevant experience preferred.
• Previous experience in a regulated environment preferred.
• Must understand laboratory instrumentation.

Responsibilities

• Maintain lab operations (cleaning, supplies, waste disposal).
• Conduct test methods for in-process, drug substance, and stability.
• Own and author quality system events (investigations, deviations, CAPAs, change controls).
• Demonstrate a functional understanding of SOPs and QC procedures.
• Work in lab environments for extended periods, facilities monitoring and product tests.
• Complete testing including special projects and protocol testing timely.
• Maintain data integrity and compliance with SOPs and cGMP.
• Independently apply judgment in QC methods and troubleshooting.
• Initiate and own laboratory investigations, deviations, CAPAs, change controls in the electronic QMS.
• Participate in cross-functional teams and train new QC Analysts.

Skills

Lab instrumentation

Communication

English proficiency

Computer basics

Interpersonal skills

cGMP knowledge

Safety procedures

Learning mindset

Education

Life Sciences degree

Tools

LIMS

Endoscan

MODA

Job description

Takeda is seeking a Quality Control Analyst II in Brooklyn Park, MN to execute and review routine sampling and test methods across in-process, drug substance, and stability programs. You will work with LIMS, Endoscan, and MODA systems to collect data and ensure data integrity within cGMP guidelines.

This role requires 3–6 years in a regulated lab, strong instrumentation knowledge, and the ability to communicate effectively in English.