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Job: Quality Systems Engineer - Biotech, Elevation Oncology, Raleigh, NC
Quality Systems Engineer - Biotech
Raleigh, NC 99999 United States
It takes a team to reach the summit.
Join us to build a future in which each patient has access to the right physicians, the right tests, and the right therapeutics to treat their individual tumor.
Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers has an opening for an experienced Quality Engineer.
In this role, you will be responsible for supporting and improving the current Quality Systems at Elevation Oncology. The Quality Engineer will have a wide range of tasks including supporting deviation investigations, internal/external auditing, document control and document management. The Quality Engineer will have direct involvement and collaboration with the Clinical Operations, Project Management and CMC groups to drive a quality-focused culture.
Responsibilities include, but not be limited to:
Support investigations, deviations and NCMRs from external CMO’s
Perform internal and external audits of systems and suppliers
Review master and executed batch records generated at external CMO’s
Support Process Sciences & Engineering in data collection and review
Organize and maintain documentation according to Elevation Oncology’s document lifecycle procedures.
Archive inactive records in accordance with the records retention schedule.
Responsible for maintaining and controlling the document revision process at Elevation Oncology; includes issuing documents for training, managing the revision process and logging document revision requests.
Create new document templates as needed.
Perform trending of Quality Systems.
Improve existing procedures to align with cGMP and regulatory requirements.
Interpret and properly apply all applicable regulatory requirements.
Support and assist with the management of supplier quality.
Additional responsibilities as assigned.
Life at Elevation Oncology
Our values lay the foundation for the road ahead:
We’re committed to identifying and targeting the genomic targets that can make the most meaningful difference to a patient, no matter how rare. Each tumor is unique, and every patient deserves access to a drug that is made with their tumor in mind, whether made by Elevation Oncology or an industry peer.
We celebrate the unity in our shared mission and the diversity of our strengths both as individuals in a team, and as a company in a vibrant precision medicine community. We actively seek and nurture effective collaborations and strive to be a trustworthy corporate citizen.
We advocate for the widespread adoption of genomic testing and a cooperative effort supporting patient awareness and education. We believe that only as a unified industry can we can best provide our patients with a clear path forward.
Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.
Required Skills & Qualifications:
Bachelor’s degree, or higher, and a minimum of 5 years of experience in a cGMP biologics in
CQA or CQE certification, preferred
Experience with and demonstrated proficiency in global GxPs.
Strong ability to prioritize own work, multitask and troubleshoot issues.
Excellent spoken and written communication skills; must be results-orientated.
Ability to communicate with internal stakeholders at multiple levels and work in a fast-paced environment with varying deadlines.
Must be located within and authorized to work in the United States today and in the future.
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North Carolina Biotechnology Center