Quality Assurance Specialist
Position: Quality Assurance Specialist
Location: Irvine, CA
Posted: January 10, 2022
Who we are:
Oncocyte is a precision diagnostics company with a mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey.
Mission of the role:
The Quality Specialist reports to the Director of Regulatory and Quality and is responsible for maintaining quality processes and documentation for Oncocyte’s proprietary diagnostic tests. Key duties include quality support for laboratory operations and pharma services, root cause investigations, and quality process improvements. A track record of learning new processes, taking on varying tasks/projects, and impeccable attention to detail is essential for this role.
- Participate in the use of the eQMS system and expanded applications as appropriate.
- Lead activities related to the following quality processes:
- Nonconformance Management
- Corrective and Preventive Actions (CAPA)
- Supplier Quality
- Equipment Management
- Coordinate/ Assist in the activities related to the following quality processes:
- Design Control
- Technical File development
- Risk Management
- Management Review
- Participate/Assist in the activities related to the following quality processes:
- Complaint investigations
- Internal audits
- Regulatory documentation
- Assist in the execution of efficiency improvement projects.
- Participate in QA programs, procedures, and controls to ensure that processes for products conform to established standards and agency guidelines.
- Work with operating entities to develop solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
- Interface with contract manufacturers and suppliers to address documentation and compliance issues.
- Exercise judgment within well-defined and established procedures and practices to determine appropriate action.
- Assist in the development and implementation of inspection readiness.
- Assist senior staff during regulatory inspections or other audits.
- Assist in the maintenance of electronic and/or hard-copy archives for applicable GMP records.
- Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
- Other tasks as assigned.
What it takes to do this job:
- Bachelor’s degree or equivalent experience.
- 2+ years of QMS experience working in a regulated, GMP environment/industry.
- At least 1 year of quality assurance experience within a regulated industry.
- Six Sigma or ASQ certification preferred.
- Must have strong writing skills to present findings clearly and concisely.
- Proficient in excel and demonstrate competency in graphs, metrics, trending using excel function.
- Experience with eQMS / ERP systems is a plus.
- Working knowledge and understanding of Medical Device regulations and standards such as 21 CFR 820, ISO 13485, and ISO 14971.
Who you are:
- You have a “do what it takes – no job is too small” team player and a positive attitude with a willingness to wear other hats and step in to perform and support other roles when needed.
- You have superb written and verbal skills and an exceptional ability to communicate clearly and professionally.
- Your organizational skills, attention to detail, and ability to multi-task are excellent.
- You like building effective internal and partner relationships including with team members, clients, vendors, suppliers, and team members.
You will have the opportunity to:
- Improve patient outcomes.
- Meaningfully impact the company’s short-term and long-term success.
- Work collaboratively across all levels within the organization.
- Grow your role as you see fit.
- Learn everything there is to know about cancer diagnostic laboratories.
- Create an inspiring workplace.