Sr. Quality Assurance Specialist

2 days ago

Salt Lake, Utah, United States Denali Therapeutics Full time

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

We are seeking a detail-oriented and experienced Senior QA Specialist to support biologics manufacturing operations. The QA Specialist will play a key role in ensuring compliance with cGMP standards, internal procedures, and regulatory requirements.

Key Accountabilities/Core Job Responsibilities:

  • Provide on-the-floor QA support for manufacturing operations across all production areas.

  • Perform electronic batch record review and QA approval of in-process and finished product documentation.

  • Review GMP documentation for product disposition including, inventory verifications, batch records, investigations, change control, laboratory reports, validation protocols and reports, calibration and maintenance documentation and batch summary reports

  • Support internal and external audits

  • Support environmental monitoring investigations and aseptic process assessments

  • Support root cause analysis and corrective/preventive actions for complex quality events

  • Collaborate cross-functionally—including Process Dev, QC, Manufacturing, and Validation—to support scale‑up, tech transfer, and inspection readiness

  • Support raw material and lot release activities and quality system updates as needed

  • Represent Quality for technology transfers and new product introductions

  • Work with accuracy, urgency and a continuous improvement perspective

​

Qualifications/Skills:

  • Bachelor's degree in life science, biology, biotechnology, or a related scientific discipline.

  • 5+ years of experience in QA or QC within a biologics or pharmaceutical manufacturing environment.

  • Previous experience working in a GMP regulated facility

  • Familiarity with large molecule drug substance manufacturing, cleanroom practices, and microbiological testing methods.

  • In depth understanding of cGMP, FDA, and EU regulatory requirements.

  • Excellent communication, documentation, and organizational skills.

  • Ability to make key quality decisions on the floor

  • Ability to work independently and collaborate effectively with cross-functional teams.

  • Familiar with Master Control, LIMS and Kneat applications

Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at 

This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salt Lake City Drug Testing Policy

  • Quality Assurance Manager

    6 days ago

    Salt Lake, Utah, United States State of Utah Full time

    The Utah Department of Transportation (UDOT) is seeking a highly capable and experienced Quality Assurance & Compliance Manager to serve as a critical technical leader overseeing key compliance and quality programs essential to maintaining the integrity of our transportation infrastructure projects. This is a unique opportunity to lead and refine the...

  • Sr. Specialist, Industrial Security

    1 week ago

    Salt Lake, Utah, United States L3Harris Technologies Full time

    L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do. Our employees are unified in a shared dedication to our customers' mission and quest for professional growth. L3Harris provides an inclusive, engaging environment designed to empower employees and promote work-life success. Fundamental to our...

  • Quality Assurance Tech

    1 week ago

    Salt Lake, Utah, United States Stone Ground Bakery and Wheat Montana Full time $18

    Job Details Level:    Experienced Job Location:    Stoneground Bakery - Salt Lake, UT Position Type:    Full-Time/Part-Time Salary Range:    $ $18.00 Hourly Job Shift:    Any DescriptionAbout Us:Stone Ground Bakery and Wheat Montana Bakery and Deli is a leading Intermountain bakery and premium flour producer dedicated to crafting...

  • Senior Quality Assurance Engineer

    11 hours ago

    Salt Lake, Utah, United States Fidelity TalentSource Full time

    Fidelity TalentSource is your destination for discovering your next temporary role at Fidelity Investments. We are currently sourcing for a Senior Quality Assurance Engineer in our Salt Lake City, UT officeWe are seeking highly talented and experienced quality assurance engineers to join our team, dedicated to planning, designing, and executing test...

  • Sr. Specialist, Manufacturing Engineer

    2 days ago

    Salt Lake, Utah, United States L3HHCM20 Full time

    Title: Sr. Specialist, Manufacturing EngineeringJob Code: 32107Location: Salt Lake City, UTJob Schedule: 9/80, 1st Shift, Employees work 9 out of every 14 days – totaling 80 hours worked – and have every other Friday off Job Description:The Sr. Specialist, Manufacturing Engineering is responsible for technical and administrative support of multiple...

  • Quality Lab Technician

    10 hours ago

    Salt Lake, Utah, United States First Quality Full time

    Founded over 35 years ago, First Quality is a family-owned company that has grown from a small business in McElhattan, Pennsylvania into a group of companies, employing over 5,000 team members, while maintaining our family values and entrepreneurial spirit. With corporate offices in New York and Pennsylvania and 8 manufacturing campuses across the U.S. and...

  • Quality Lab Technician

    1 hour ago

    Salt Lake, Utah, United States First Quality Full time

    Founded over 35 years ago, First Quality is a family-owned company that has grown from a small business in McElhattan, Pennsylvania into a group of companies, employing over 5,000 team members, while maintaining our family values and entrepreneurial spirit. With corporate offices in New York and Pennsylvania and 8 manufacturing campuses across the U.S....

  • Quality Assurance Manager

    9 hours ago

    Salt Lake, Utah, United States Varex Imaging Full time

    To apply to a Varex Imaging position, please create an account and sign-in.CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account.SummaryDevelops, implements, and maintains technical quality assurance and control systems and activities. Defines and specifies the implementation of standards, methods, and procedures for...

  • Supplier Quality Assurance Engineer II

    12 hours ago

    Salt Lake, Utah, United States T.D. Williamson Full time

    At TDW we put people first - that means working everyday to ensure the pipelines that run through our communities are operating safely and reliably. What sets us apart is our expertise, experience and commitment.Each day we dedicate ourselves to treating each other, our customers and our community with care and respect.OverviewThe Quality Assurance Engineer...

  • Food Safety Quality Assurance Technician III

    3 hours ago

    Salt Lake, Utah, United States Charcuterie Artisans Full time

    **Please note the schedule for this position is Mon-Fri 10:00AM-6:30PM, Saturdays as needed** FSQA Technician III is an advanced-level technician responsible for executing and supporting food safety and quality assurance programs across production shifts. This role serves as a technical resource for FSQA Tech I and II team members, leads routine...