What are the responsibilities and job description for the Specialist, Quality Assurance position at Denali Therapeutics?
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.
The Quality Assurance Specialist will play a key role in supporting GMP operations and ensuring the highest quality standards are being met in all areas across the facility. They will contribute to implementing and driving quality systems and driving continuous improvement.Key Accountabilities/Core Job Responsibilities:
- Participate actively in Quality Systems, including Deviations, Change Control, CAPA, Training, and Risk Assessments
- Participate and approve the development and implementation of standard operating procedures, policies and work instructions for processes throughout the facility
- Provide 'On the Floor ' support for manufacturing operations and key quality decision maker
- 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
- Provide disposition recommendations for raw material and products
- Represent Quality for technology transfers and new product introductions
- Work with accuracy, urgency and a continuous improvement perspective
- Provide quality oversight for manufacturing and testing of GMP products
- Provide flexible support for on-call or outside normal business hours if required
Qualifications/Skills
- BS in a core scientific discipline
- 4 years of experience in Biotech Manufacturing / Quality Assurance / Quality Control
- Familiarity with large molecule drug substance manufacturing
- Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance
- Ability to work with independently with guidance or in team environments under deadlines
- Previously experience working in a GMP regulated facility
- Well-developed verbal and written communication skills
- Ability to closely follow quality standards and have attention to detail
- Strong collaboration skills
- Excellence in execution through accuracy, right first time and a proactive nature
- 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 https://www.denalitherapeutics.com/careers
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.
