Quality Assurance Specialist

Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases. 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 QA Specialist to support biologics manufacturing operations. This role requires coverage of Wednesday through Sunday operations, with a particular focus on weekend responsibilities related to QA on-the-floor and supporting microbiological sampling and testing. 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 Conduct and support routine audits and walkthroughs of production and cleanroom areas. Support environmental monitoring investigations and aseptic process assessments. Perform Microbiological sampling and testing for environmental/utility samples and personnel monitoring on weekends, ensuring compliance with compendial and internal standards. Collaborate with QC and Manufacturing teams to ensure timely and compliant execution of sampling plans. 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 microbiology, biology, chemistry, or a related scientific discipline. 4+ 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. Working knowledge of microbiological sampling techniques preferred. Strong 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 on a weekend schedule and collaborate effectively with cross-functional teams. Familiar with Master Control, LIMS and Kneat applications Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. 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.

#J-18808-Ljbffr