Quality Assurance Specialist (Remote)
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 Assurance Specialist to support Upstream or Downstream Manufacturing. Our Quality Assurance team ensures our products are manufactured, processed, tested, packaged stored and distributed in accordance with Elevation Oncology’s high standards of quality and that they meet all regulatory requirements.
In this remote role, you will be responsible for supporting manufacturing activities of our vendors at Elevation Oncology. The Quality Assurance Specialist will have a wide range of tasks including supporting deviation investigations, internal/external auditing, batch record review and lot disposition. Reporting to the Associate Director of Quality the Quality Assurance Specialist will have direct involvement and collaboration with Project Management and CMC groups to drive a quality-focused culture.
Responsibilities include, but are not limited to:
- Quality oversight of drug substance/drug product manufacturing operations at external CMOs, to ensure Elevation product is manufactured in adherence with all applicable regulatory requirements, industry standards, and Elevation’s quality expectations.
- Review master and executed batch records generated at external CMOs
- Conduct review and approval of quality notifications from external CMOs/Continuous monitoring for vendor material control
- Provide both quality and technical support for investigations, deviations, NCMRs and Change Controls from external CMOs
- Support Process Sciences & Engineering in data collection and review
- Develop/maintain subject matter expertise of CMOs’ manufacturing processes in assigned Drug Substance unit operation (Upstream or Downstream), to support technical activities such as tech transfers, process development, FMEAs, complex investigations/RCAs, etc.
- Perform internal and external audits of systems and suppliers
- Support the preparation of regulatory filings by providing data and review
- Identify and implement improvements to existing procedures in alignment with cGMP and regulatory requirements.
- Interpret and properly apply all applicable regulatory requirements.
- Support and assist with the management of supplier quality.
- Write, review, and approve Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc. where required
- Represent Quality on assigned project teams and lead projects relevant to Quality where needed
- Additional responsibilities as assigned.
Required Skills & Qualifications:
- Bachelor’s degree, or higher, in a life sciences or engineering field, and a minimum of 5 years of experience in a cGMP biologics manufacturing environment with preference given to experience with drug substance manufacturing of (Upstream and/or Downstream) monoclonal antibodies.
- QA experience or experience owning quality system events preferred
- Experience managing external partners a plus but not required
- 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.
- Experience in preparing documents for regulatory filings a plus
- 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.
- Some travel to US and International sites may be required.
Life at Elevation Oncology
Our values lay the foundation for the road ahead:
INTEGRITY: 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.
COMMUNITY: 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.
ADVOCACY: 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.
If you share our beliefs and are interested in helping to further our mission, send your resume or CV to firstname.lastname@example.org and tell us how you’d can help. We look forward to meeting you!
Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.