Quality Control Analyst II

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

Job Description

About the role:

As a Quality Control Analyst II, you will execute and review routine in-process, drug substance, and stability test methods in a timely manner. You will use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, Charles River Endoscan, and MODA).

This shift will be working from Saturday to Tuesday.

How you will contribute:

• Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal).
• Conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability.
• Own and author quality system events (i.e., laboratory investigations, deviations, CAPA’s and change controls).
• Demonstrate a functional and basic theoretical understanding of laboratory operations and Standard Operating Procedures (SOP’s).
• Work within laboratory environment for extended periods of time, conducting facility monitoring (i.e., Environmental Monitoring and Critical Utility Monitoring) and product tests, reviewing data, maintaining laboratory materials and instruments and other laboratory functions as required.
• Complete all testing, including special project and protocol testing in a timely and appropriate manner.
• Maintain data integrity and ensure compliance with company SOP’s, specifications, and cGMP regulations.
• Independently exercise judgment within generally defined Quality Control (QC) procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate solutions.
• Decisions have moderate impact on future QC processes and procedures that impact batch disposition.
• Initiate and own laboratory investigations, basic complexity low and medium risk deviations, CAPA’s, and change controls of moderate scope within the electronic Quality Management System.
• Participate in cross-functional teams.
• Draft studies and investigations of moderate scope and work on problems where the situation or data requires a review of identifiable factors.
• Author new SOP’s and initiate changes to existing procedures.
• Train new QC Analysts on routine procedures and practices.
• May be required to work overtime or be assigned to a different shift as needed.
• Perform equipment maintenance and calibrations as required.
• Complete mandatory training within required timeframe.
• Perform other duties as assigned.

What you bring to Takeda:

• Bachelor’s or master’s degree in any Life Sciences with relevant laboratory coursework
• 3-6 years of relevant experience preferred.
• Previous experience in a regulated environment preferred.
• Must understand laboratory instrumentation.
• Must be able to communicate effectively with managers and peers.
• Must be able to read, write, and converse in English.
• Must have basic computer skills. General use of word processing, spreadsheets, databases, etc. for the purposes of work execution, training, performance management, and self-service.
• Good interpersonal skills and able to work effectively and efficiently in a team environment.
• Knowledge of cGMP manufacturing
• Knowledge of chemical, biological and/or microbiological safety procedures.
• Must display eagerness to learn and continuously improve.

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.
• Stand or sit -> Must be able to remain in a stationary or standing position for extended periods of time in both office and laboratory environment.
• Carry weight, lifting - Frequently moves laboratory materials and portable instruments weighing up to 30 pounds.
• Climb - Occasionally ascends/descends step ladders to reach materials and/or stairs to collect samples.
• Dexterity/balance – required to gown for cleanroom work, balance and dexterity are required.
• May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.
• Willingness to travel to various meetings or training, this could include overnight trips.
• Requires 0-5% travel.

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-MA1

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:

Brooklyn Park, MN

U.S. Hourly Wage Range:

$24.76 - $38.87

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.

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

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No