QUALITY CONTROL ANALYST I

Job Description Job Title.
Quality Control Analyst I Location.
Brooklyn Park, MN About the role.
You will report to the Team Lead- Quality Control Build routine in-process, drug substance, and stability test methods.
Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower).
Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal).
How you will contribute.
Demonstrate a functional understanding of a laboratory setting and Standard Operating Procedures (SOP's).
Work within laboratory environment for extended periods of time, conducting facility monitoring (i.
., 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.
Support low risk deviations, CAPA's and change controls within the electronic Quality Management System.
Initiate and own laboratory investigations.
Occasionally participate in department problem-solving.
Author minor revisions to existing SOP's.
Receive general instructions on routine work and detailed instructions on new assignments.
What you bring to Takeda.
Bachelor's or master's degree in any Life Sciences with relevant laboratory coursework.
0-3 years of relevant experience.
Previous experience in a regulated environment.
Laboratory instrumentation experience preferred.
Knowledge of cGMP manufacturing preferred.
Other Job Requirements Physical Demands.
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.
In certain areas of Quality Control, the following may apply.
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 stairs to collect samples.
Dexterity/balance – required to gown for cleanroom work, balance and dexterity.
Other / Travel Requirements.
May wear personal protective equipment (PPE) and other clean room garments daily.
This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
May participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.
Additional preferred skills include, but are not limited to.
QC Analytical Skills – HPLC, UPLC, UV-Vis, Appearance, Concentration, pH, CE, Osmolality, TOC, strong micropipetting skills QC Bioassay Skill Set – ELISA's, Cell Maintenance, Cell-Based Assays, plate readers, Gels, icIEF, Aseptic Technique, strong micropipetting skills, biosafety cabinets QC Micro Skills – Endotoxin, Bioburden, Environmental Monitoring, Manufacturing Cleanrooms, Aseptic Technique, Critical Utility systems 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.
May be required to wear personal protective equipment (PPE) and other clean room garments daily.
This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
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-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.
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Hourly Wage Range.
$ 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.
U.
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based e mployee s may be eligible for s hort - t erm incentives.
U.
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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.
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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.