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QC Analyst III - 2nd Shift

Brooklyn Park, Minnesota

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
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  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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QC Analyst III - 2nd Shift

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Job ID R0020951 Date posted 10/07/2020 Location Brooklyn Park, Minnesota

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Job Description

  • Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Control Analyst III in our Brooklyn Park office.

    At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

    Here, you will be a vital contributor to our inspiring, bold mission.

    As a Quality Control Analyst III working on the team, you will be empowered to help increase quality and service to both internal and external clients. In this role, you will contribute to Takeda’s mission by helping to build a better tomorrow for our patients and their families. This position will support second shift in the Quality Control Lab (2:00-10:30 PM, M-F) A typical day will include:

    SHIFT: Evenings, Monday - Friday, 2:00 pm - 10:30 pm

    OBJECTIVES:  

    • Perform activities for general lab readiness, laboratory equipment qualification, and method transfers.

    • Conduct critical biological test methods including samples generated for in-process, drug substance, and stability.

    • Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS and Empower). 

    • Independently prioritize and perform routine and non-routine methods requiring precise analytical skills and understanding of biology and chemistry principles. 

    ACCOUNTABILITIES:  

    • Demonstrate an in-depth theoretical understanding of laboratory operations, systems, and methods. 

    • Complete all testing, including special project / protocol testing in a timely and appropriate manner. 

    • Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations. 

    • Independently exercise judgment for broadly defined practices, procedures, and policies to select methods, techniques, and evaluation criteria.  Obtains results, troubleshoots problems, and formulates solutions.

    • Decisions have a high impact on future Quality Control processes and procedures and may affect other departments within the organization.

    • Serve as a point person for particular assays and/or equipment and systems.

    • Work within laboratory environment for extended periods of time, conducting analytical tests, reviewing analytical data, maintaining laboratory materials and instruments and other laboratory functions as required

    • Perform laboratory instrument qualification.

    • Initiate and own deviations, CAPAs, and change controls within the electronic Quality Management System.  

    • Drafts studies and investigations of moderate scope and works on problems in which the analysis of the situation or data requires a review of identifiable factors.

    • Revises and authors new SOPs and study documentation.

    • Receives minimal instruction on new assignments.

    • Provides mentoring, training and may serve as Lab Lead to direct work of lower level QC Analysts.

    • Coordinates projects within the QC department.

    • May interact as a technical resource with collaborators, stakeholders, and vendors.

    • May perform equipment maintenance and calibrations as required.

    • Complete mandatory training within required timeframe.

    • Perform other duties as assigned.

    EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: 

    • Bachelor’s or Master’s Degree in any Life Sciences with relevant laboratory coursework 

    • 7+ years of relevant experience preferred.

    • Previous industry experience in a regulated environment highly desired.

    • Ability to handle multiple tasks concurrently, and in a timely fashion. 

    • Must have understanding of laboratory instrumentation. 

    • Must be able to communicate effectively with managersand 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 preferred.

    • Knowledge of basic chemical and biological safety procedures.

    • Must display eagerness to learn and continuously improve.

    • Must have the following personal attributes:  integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.

    LICENSES/CERTIFICATIONS:

    • NA

    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/or stairs to collect samples.

    • Dexterity/balance – required to gown for cleanroom work, balance and dexterity are required.

    OTHERREQUIREMENTS:

    • 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.

    • 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 approximately 5% travel.

    ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY):

    • QC Analytical Skill Set – HPLC, Appearance, Concentration, pH, CE, Particulate Matter, Osmolality

    • QC BioAssay Skill Set – ELISAs, Cell Maintenance, Cell-Based Assays, Gels

    • QC Micro Skill Set – Endotoxin, Bioburden, Environmental Monitoring, Cleanrooms, Aseptic technique, Pharmaceutical water systems

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0020951

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