What are the responsibilities and job description for the Specialist, Quality Document Control 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 Document Control Specialist will play a key role in supporting Good Manufacturing Practices (GMP) Documentation creation and management to ensure 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
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.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
The Quality Document Control Specialist will play a key role in supporting Good Manufacturing Practices (GMP) Documentation creation and management to ensure 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
- Manage the processing, routing, and distribution of cGMP documentation in alignment with Salt Lake City (SLC) manufacturing requirements
- Serve as a subject matter expert for electronic document management systems, providing user training and support as needed
- Work with accuracy, urgency and a continuous improvement perspective on the management of electronic records
- Develop and manage executable electronic process flows in electronic systems with the content, approvals and functional area support
- Ensure GMP compliance in all documentation control activities to meet expectations based on Quality Management System (QMS) requirements.
- Administrate Document Control / Document Management System according to site, corporate and regulatory standards to include processing of document revisions/implementations, periodic review of documents, retrieval and archiving of documents, and security of electronic copies
- Complete workflows, document gating and coordinate elements of the document change process to ensure minimal disruption to site operations
- Initiating and management of documents in MasterControl
- Bachelors in science degree or 4 years of related work experience
- 4 years of experience in the Biotech industry or GMP regulated environment
- Understanding and application of GMP principles, concepts and practices
- Ability to work with independently with guidance or in team environments under deadlines
- Well-developed verbal and written communication skills
- Ability to closely follow quality standards and have attention to detail
- Strong project management skills
- Strong collaboration skills
- Experience with document control systems such as MasterControl, Veeva or equivalent
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.
