Jobs
>
Los Angeles

    Senior Quality Analyst - Los Angeles, United States - Takeda Pharmaceutical Company Ltd

    Takeda Pharmaceutical Company Ltd
    Takeda Pharmaceutical Company Ltd Los Angeles, United States

    3 weeks ago

    Default job background
    Description

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

    Job Description

    This position reports to Shift (3) Nights, which includes a shift differential according to the shift schedule. This shift schedule is Monday-Friday from 10 PM to 6:30 AM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift. The company reserves the right to adjust your shift schedule, or location if necessary.

    About the role:

    You will perform all primary Quality Assurance activities for Teardown, Fractionation, and Purification observing cGMP, GDDP, FDA and Regulatory Standards, ISO requirements, and internal standard operating procedures. You will provide daily Quality on the Shop Floor oversight to manufacturing batch record and documentation review for accuracy and compliance to procedure, Quality on the Shop Floor walkthroughs to assure cGMP compliance and resolution of issues, participating in troubleshooting and problem solving of manufacturing issues and supporting daily Return to Operation assessment and Change Control (insignificant changes) process.

    You will provide Quality Assurance support to Site Critical Systems, Facilities and Engineering processes.

    You will assure compliance with cGMP, GDDP, and company procedures internal and external audits. Identify potential Quality and compliance risk in activities and processes according to procedural requirements, Takeda Quality Standards. Provide assessments to support good understanding of current regulatory requirements i.e., FDA, ISO, and Takeda Quality Systems, and serve as a plant resource for compliance to these requirements. Uphold Takeda's Quality Culture elements of keeping it simple, taking pride in doing it right, ensuring a speak up culture and overseeing and demonstrating commitment to Quality.

    How you will contribute:

    • Partner up with Manufacturing for Quality on the Shop Floor collaboration to ensure sound Quality decisions are made with compliance to standards and procedures.
    • Perform scheduled and unscheduled walkthroughs of Manufacturing, facilities, and supporting areas for verification of acceptable cGMP Facilities and equipment conditions.
    • Obtain resolution on issues identified as non-conformance. Interpret and evaluate issues for acceptability to standards, procedures and regulatory requirements. Help document issues with immediate corrections and corrective actions.
    • Work with manufacturing teams in proactive functions that impact production, solve problems, improve quality, increase efficiency, create cost savings, and provide new product support.
    What you bring to Takeda:
    • High school diploma or GED. 6+ years of experience or AA or higher with 4+ years related work experience
    Qualifications
    • Knowledge of Regulations, Application of Good Data and Documentation Practices (GDDP) and application of current Good Manufacturing Practices (cGMP).
    • General knowledge of biopharmaceutical / biotech manufacturing industry and systems.
    • Good investigational experience. See the actual process on the floor (GEMBA) where issue occurred and recommend immediate corrections and corrective actions for determined root cause.
    • Have good critical thinking and problem-solving skills (DMAIC and Lean).
    • Perform and analyze trending using DeltaV system and EBM.
    • Support department / plant goals.
    • Approve investigations as assigned
    • Yellow Belt/ Green Belt training or certification.
    Physical Demands
    • Must be able to lift, pull, and carry up to 25 lbs.
    • In general, you will have a combination of sedentary work and walking around observing conditions in the cGMP facility.
    Working Environment
    • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
    • Will work in a cold, wet environment.
    • May work in a confined area.
    • Some clean room and cool/hot storage conditions.
    Other Job Requirements
    • Must be able to work multiple shifts, including nights, as assigned.
    • Will work periodic overtime.
    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. You may:
    • 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.
    • Need to remove all make-up, jewelry, contact lenses, nail polish and 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,.
    • 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:
    USA - CA - Los Angeles

    U.S. Hourly Wage Range:
    $ $42.31

    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.S. based employees may be eligible for short-term incentives. U.S. 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.S. 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.

    Locations

    USA - CA - Los Angeles

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time
  • eSystems Inc.

    Quality Analyst

    1 week ago

    eSystems Inc. Los Angeles, United States

    Job Description · Job DescriptionWe are seeking a detail-oriented and experienced Remote Quality Analyst to join our Quality Assurance team. The ideal candidate will be responsible for ensuring the quality of our products and services through thorough testing and analysis. This r ...

  • CommonSpirit Health

    Quality Analyst

    3 weeks ago

    CommonSpirit Health Los Angeles, United States

    Overview: · Founded in 1887 Dignity Health - California Hospital Medical Center is a 318-bed acute care nonprofit hospital located in downtown Los Angeles. The hospital offers a full complement of services including a Level II trauma center the Los Angeles Center for Womens Healt ...

  • Triller Platform Co

    Quality Assurance Analyst

    5 days ago

    Triller Platform Co Los Angeles, United States

    Job Description · Job DescriptionABOUT TRILLER: · Triller is leading a revolution to connect brands, creators, and audiences with cultural experiences, music, sports, fashion, and entertainment. Triller's Creator Marketing and Social Engagement solutions allow brands and creator ...

  • Takeda Pharmaceutical Company Ltd

    Senior Quality Analyst

    3 weeks ago

    Takeda Pharmaceutical Company Ltd Los Angeles, United States

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...

  • CommonSpirit Health

    Quality Analyst

    3 weeks ago

    CommonSpirit Health Los Angeles, United States

    Overview: · Founded in 1887 Dignity Health - California Hospital Medical Center is a 318-bed acute care nonprofit hospital located in downtown Los Angeles. The hospital offers a full complement of services including a Level II trauma center the Los Angeles Center for Womens Heal ...

  • Upward Bound House

    data & quality assurance analyst

    1 week ago

    Upward Bound House Los Angeles, United States

    Job Description · Job DescriptionSalary: $25 - $30 per hour · Organizational Overview · Upward Bound House (UBH) is dedicated to ending the cycle of intergenerational family homelessness. We compassionately provide a continuum of services ranging from crisis housing to permanent ...

  • Infinite Computer Solutions

    Quality Analyst

    3 weeks ago

    Infinite Computer Solutions Los Angeles, United States

    16916BR · California · Job Description · Monitor and measure the quality of inbound and outbound customer service calls. · Prepare and present audit reports for management to identify issues and performance · Assist with feedback and training of L1 / L2 representatives who hav ...

  • Upward Bound House

    data & quality assurance analyst

    1 week ago

    Upward Bound House Los Angeles, United States

    Organizational Overview · Upward Bound House (UBH) is dedicated to ending the cycle of intergenerational family homelessness. We compassionately provide a continuum of services ranging from crisis housing to permanent housing and homelessness prevention. With over 30 years of ex ...

  • MSIT

    Quality Analyst

    3 weeks ago

    MSIT Los Angeles, United States Full time, Part time, Contract, Training

    Responsibilities Verify by wet chemistry or instrumentation the percent alcohol total acid specific gravity color clarity sugar content preservatives and the pH on all products from processing. Verify components are in spec and packaging materials are correct. Verify tightness of ...

  • RenaudExec & Associates Inc.

    Analyst, Quality Control

    3 weeks ago

    RenaudExec & Associates Inc. Los Angeles, United States

    Our client, a Canadian pharmaceutical company with fully integrated infrastructures for R&D, manufacturing, distribution, and marketing, is looking for a Quality control analyst for their laboratory. Their vast product line includes innovative and generic products as well as over ...

  • Kaiser Permanente

    Quality Program Analyst

    2 weeks ago

    Kaiser Permanente Los Angeles, United States

    : Job Summary: · Receiving oversight from the Quality Coordinator, and reporting directly to the Assistant Area Administrator, the Quality Program Analyst-Care at Home maintains ongoing quality and performance improvement projects. Participates in risk management and identificat ...

  • Takeda

    Senior Quality Analyst

    2 weeks ago

    Takeda Los Angeles, United States

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...

  • Cisco

    Quality Data Analyst

    3 weeks ago

    Cisco Glendale, United States

    The purpose of this role is to extract, collate and provide initial validation for Security Business Groups (SBG) Quality Data that currently resides on multiple systems. The combined and validated data that is the output of this process will be used to generate the weekly, month ...

  • ServiceTitan

    Data Quality Analyst

    6 days ago

    ServiceTitan Glendale, United States

    Ready to be a Titan? · ServiceTitan is looking for a Data Quality Analyst to join our Data Engineering department. Strong candidates will have basic knowledge of the SQL server, TSQL, and ETL operations in addition to strong analytical and critical thinking skills. The most crit ...

  • TaxPlus

    Quality Assurance Analyst

    1 week ago

    TaxPlus Los Angeles, United States

    Job Summary: · **Duties**: · - Work hand in hand with our tax specialist to ensure all tax returns are filed with governing agencies. · - Reach out to clients remotely to collect payment and digital signatures. · - Other administrative duties such as answering phones, scheduling ...

  • Mondo

    Business/ Data Quality Analyst

    4 weeks ago

    Mondo Los Angeles, United States

    Job Title: · Business/Data Quality Analyst · Location-Type: · San Francisco, CA · Start Date Is: · 2 weeks from offer · Duration: · 5+month contract · Compensation Range: · $60-$80/hr · Summary: · We are seeking an experienced Business/Data Quality Analyst to serve as a pi ...

  • That's No Moon Entertainment

    Associate Quality Assurance Analyst

    2 days ago

    That's No Moon Entertainment Los Angeles, United States

    That's No Moon is an independent studio of storytellers and game-makers who believe in the power of narrative-driven experiences. With a diverse team of talented developers, from some of the top game studios in the world (Naughty Dog, Infinity Ward, Bungie), our shared vision is ...

  • Upward Bound House

    Data & Quality Assurance Analyst

    1 week ago

    Upward Bound House Los Angeles, United States

    **Organizational Overview** · Upward Bound House (UBH) is dedicated to ending the cycle of intergenerational family homelessness. We compassionately provide a continuum of services ranging from crisis housing to permanent housing and homelessness prevention. With over 30 years of ...

  • Tik Tok

    Content Quality Analyst, TikTok LIVE

    2 weeks ago

    Tik Tok Los Angeles, United States

    Responsibilities · About TikTok · TikTok is the leading destination for short-form mobile video. At TikTok, our mission is to inspire creativity and bring joy. TikTok's global headquarters are in Los Angeles and Singapore, and its offices include New York, London, Dublin, Paris ...

  • Mitchell Martin Inc

    Quality Assurance Analyst Engineer II

    1 month ago

    Mitchell Martin Inc Los Angeles, United States Full time

    Our Client, Provides health insurance for low-income individuals, is seeking an Quality Assurance Analyst Engineer II · Location: Southern California · Position Type: IT Full Time · Duties:Review business requirements, system documentation and project assets to create robust, acc ...