Quality Assurance Specialist

At Denali Therapeutics, Inc.

Salt Lake City, UT

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degenerative biology and the principles of translational medicine.

The Opportunity

Denali Therapeutics, Inc. seeks a Quality Assurance Specialist for its Salt Lake City, Utah location.

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, new product introductions, and other cross-functional initiatives to support process improvement efforts. Work with accuracy, urgency and a continuous improvement perspective

Required qualifications

Must have a minimum of a Master’s degree or foreign equivalent in biology, microbiology, biotechnology, chemistry, or related scientific field and 3 years of experience in Quality Assurance or Quality Control within a biologics or pharmaceutical manufacturing environment or GMP regulated facility. Will also accept a Bachelor’s degree or foreign equivalent in the above stated fields and 5 years of progressive, post baccalaureate experience in Quality Assurance or Quality Control within a biologics/pharmaceutical manufacturing environment or GMP regulated facility. Must have at least three (3) years of experience with:

• Providing GMP compliance QA support for manufacturing operations in the biopharmaceutical industry, quality oversight and/or management of quality event investigations, impact assessments, and resolution of issues affecting batch disposition.
• Managing, authoring, reviewing and/or approving GMP documentation - SOPs, batch records, investigations, deviations, risk assessments, CAPAs, change controls, QC records, validation or qualification documentation and other quality records;
• Conducting and/or supporting inspection readiness activities, internal audits, and health regulatory inspections;
• Supporting supplier and raw material quality programs, vendor qualification and oversight, maintenance of supplier qualification records within QMS, raw material qualification and disposition, and review of quality events related to suppliers or incoming materials;
• Representing and/or partnering with Quality involving cross-functional stakeholder management for initiatives: investigations, technology transfers, new product introductions, process implementation, risk mitigation initiatives, and continuous improvement efforts within GMP-regulated environments.
• Salary Range: $103,000 - $104,000. 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 https://www.denalitherapeutics.com/careers.