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　　Job Description

　　Job Title: Quality Control Analyst III

　　Location: Brooklyn Park, MN

　　About the role:

　　You will own and troubleshoot laboratory equipment qualification, method verification, qualification, validation, and transfer. You will demonstrate an in-depth and high level theoretical understanding of laboratory operations, systems, and methods.

　　This is an on site position that works Friday-Monday 10 hour shifts, and reports to the Quality Control Manager.

　　How you will contribute:

　　Independently complete all testing, including special project or protocol testing.

　　Maintain data integrity and ensure compliance with company SOP's, specifications, and cGMP regulations.

　　Independently exercise judgment for broadly defined practices, procedures, and policies to select methods, techniques, and evaluation criteria that impact batch disposition. Be a resource for test methods or equipment and systems.

　　Independently troubleshoot problems, and proactively formulate solutions to present to management to define path forward. Decisions have a high impact on future QC processes and manufacturing processes and procedures and that would affect other departments and batch disposition.

　　Participate in internal or supplier audits.

　　Be a lead within the QC laboratory environment, conducting facility monitoring (i.e., Environmental Monitoring and Critical Utilities Monitoring) and product tests, review data, maintain laboratory materials and instruments and other laboratory functions. Provide training to junior QC Analysts.

　　Independently plan and perform laboratory instrument qualification.Receive minimal instruction on new assignments.

　　Initiate and own departmental and cross-functional laboratory investigations, deviations, CAPA's, and change controls 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.

　　Coordinate projects within the QC department and interact as a technical resource with internal and external collaborators, stakeholders, and vendors.

　　Perform equipment maintenance and calibrations.

　　Complete mandatory training within required timeframe and perform other duties as assigned.

　　Independently execute and review routine in-process, drug substance, and stability test methods.

　　Conduct critical test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability.

　　Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endosafe, MODA and Empower). May act as a subject matter expert (SME).

　　Lead lab operations (documentation review, testing schedule, cleaning, ordering of supplies, reagent preparation, stocking, waste disposal) and align practices with department and site SOP's.

　　Independently own and author quality system events (laboratory investigations, deviations, CAPA's and change controls). Author new SOP's, study documentation, and implement new work streams.

　　Participate in or lead cross-functional collaboration with internal departments (i.e., Quality, Manufacturing, Engineering, Metrology, and Business Excellence) and external vendors.

　　What you bring to Takeda:

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

　　6+ years of relevant experience in HPLC testing.

　　Knowledge of cGMP manufacturing.

　　What Takeda can offer you:

　　Comprehensive Healthcare: Medical, Dental, and Vision

　　Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

　　Health & Wellness programs including onsite flu shots and health screenings

　　Generous time off for vacation and the option to purchase additional vacation days

　　Community Outreach Programs and company match of charitable contributions

　　Family Planning Support

　　Professional training and development opportunities

　　Tuition reimbursement

　　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.

　　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.

　　Gown for cleanroom work.

　　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.

　　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.

　　Travel to various meetings or training, this could include overnight trips. Requires approximately 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.

　　This posting excludes Colorado applicants.

　　#GMSGQ #ZR1 #LI-MA1 #LI-Onsite

　　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