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Job Description

About the role:

As a Quality Control Analyst, you will execute and review routine in-process, drug substance, and stability test methods. You will maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal) and conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability. You will own and author quality system events (i.e., laboratory investigations, deviations, CAPA's and change controls).

This shift will require you to work Thursday to Sunday 7:00am to 5:30pm

How you will contribute:

+ Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower).

+ Demonstrate a functional and basic theoretical understanding of laboratory operations and Standard Operating Procedures.

+ 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.

+ Complete all testing, including special project and protocol testing.

+ 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 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.

+ 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 practices.

+ May work overtime or be assigned to a different shift.

+ Perform equipment maintenance and calibrations.

What you bring to Takeda:

+ Bachelor's degree in any Life Sciences with relevant laboratory coursework

+ 3+ years of experience.

+ Previous experience in a regulated environment.

+ Must understand laboratory instrumentation.

+ Must be able to read, write, and converse in English.

+ Use databases for the purposes of work execution, training, performance management, and self-service.

+ Knowledge of cGMP manufacturing

+ Knowledge of chemical, biological and/or microbiological safety procedures.

+ QC Analytical Skills – HPLC, UPLC, Appearance, Concentration, pH, Capillary Electrophoresis, Osmolality, TOC, or strong micro pipetting skills

+ QC Bioassay Skill Set – ELISAs, Cell Maintenance, Cell-Based Assays, Gels, icIEF, Aseptic Technique, micropipetting skills

+ QC Micro Skills – Contamination control, Endotoxin, Bioburden, Environmental Monitoring, Manufactuirng Cleanrooms, Aseptic Technique, Critical Utility systems

How you will contribute:

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 move 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

$32.64 - $51.30

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