Quality Assurance Specialist
San Diego Metropolitan Area
Summary of Role:
We are seeking a Quality Assurance Specialist to drive, maintain and improve our document control and training programs. The QA specialist will also support nonconformance investigations, CAPAs and product release. This role will report to the Director of Quality Assurance. A successful candidate will have an enthusiastic entrepreneurial work ethic. This person will work closely with department managers and employees to ensure compliance.
Essential Duties and Responsibilities:
- Support the development of Codex DNA quality program addressing process, hardware, software, and reagents. Ensure compliance and inspection readiness of the Quality System and manufacturing.
- Develop new processes, as appropriate, to advance the maturity and capability of the quality management system.
- Mange the document control process by initiating, reviewing, approving, and processing document control forms. Collaborate with department managers and employees to review, process, and make effective new and revised Standard Operating Procedures and Device Master Records.
- Scan/archive/maintain Device History Records, instrument records and Quality System records (e.g., document change forms, deviations, nonconformances, CAPAs, change controls).
- Work with department supervisors to ensure training compliance. Collect, file, scan and maintain training folders and records.
- Maintain training matrix and provide updates to senior management.
- Support preparations for internal and external QMS audits, including regulatory bodies and clients
- Review and approve qualification and validation protocols/reports
- Perform quality assessments for Change Controls
- Collect, process and report quality KPI metrics data
- Support Product Release as necessary
- All other duties as assigned or necessary
- 4-8 years of experience in progressive roles with manufacturing companies producing reagents and electro-mechanical products working in a quality assurance function.
- Direct experience with Quality Management Systems, Document Control, Training Program, Product Release, Nonconforming events and CAPA is required.
- Prior experience with cGMP, ISO 13485 and 21 CFR 820 is preferred
- Experience with software quality engineering is preferred
- Demonstrated ability to collaborate effectively with cross-functional teams, e.g., Process Development, Manufacturing, Quality Control and Technical Support.
- Self-motivated, hard-working, detail-oriented, and able to work in a fast-paced team environment with demonstrated data analysis and problem-solving skills.
- Excellent time management skills and ability to work independently.
- Computer literacy using Microsoft Office Suite, ERP systems, and LIMS systems.
- Excellent math skills, strong organizational skills, and strong communication skills.
- Take initiative and have a growth mindset.
- Ability to respond to and investigate urgent product and process quality issues
- Prior experience in molecular biology techniques including cloning, PCR, gene synthesis design and assembly, mutagenesis and sequence analysis is highly desirable.
- Associate’s or Bachelor’s degree in molecular biology, biochemistry or related field is required.
- ASQ certified Quality Engineer and/or Quality Auditor is preferred
- As a critical and essential role, the candidate must be willing and able to travel to the San Diego, CA office to report to work. We have protocols in place to provide a safe, socially distanced work environment.
- Prolonged periods of sitting at a desk and working on a computer
- Ability to lift up to 15 pounds required
Job type: FULL_TIME
Experience: 3 Year