Passionate about joining a company committed to translating world-first innovations into disruptive, balanced solutions for researchers, companies and consumers?
Synthetic Genomics Inc. is a synthetic biology company founded to commercialize genomic-driven technologies. Our strength lies in the decades of groundbreaking research by our founders, J. Craig Venter, Ph.D., Nobel Laureate Hamilton O. Smith, M.D., and the top tier scientific, technology and business teams they have crafted. Our team has a consistent track record of making scientific breakthroughs that translate into viable commercial solutions.
We are seeking a motivated and enthusiastic Quality Assurance professional where your skills and contributions will help us build, grow and maintain our CGMP Quality System.
You will actively support the SGI-DNA Quality System to ensure compliance with all applicable regulatory requirements. Develops and implements company and regulatory quality standards related to the cGMP manufacturing facility. Working knowledgeable and application of industry and governmental quality regulations and standards.
Duties and Responsibilities:
- Deviations, non-conformances, out of specification (OOS) test results: you will lead and/or assist investigations related to manufacturing issues. You will utilize root cause analysis techniques to implement effective corrective and preventive actions.
- Process Control: using your skills and experience, help stablish statistical confidence by identifying sample size and acceptable error; resolving levels of confidence. Apply statistical process control techniques to ensure manufacturing processes are in constant state of control. Establish process capability indices for various manufacturing processes.
- QA inspection and release of GMP raw materials: review and verification of receiving inspection documentation, verification of segregation of materials based on material status, application of material status labels, paperwork reviews and files, approved supplier list process management.
- Overall Quality System Support:
- Active voice in continuous improvement initiatives
- Monthly review of environmental monitoring data to ensure manufacturing facility operates within designed air cleanliness specifications
- Assist in batch record review and approval processes/requirements
- Coordinate the calibration and preventive maintenance program
- Perform internal and external audits
- Assist with crafting and maintaining of procedural documentation (SOPs)
- Participate in the annual “product” review: reviews documents related to products; compiles trend-analysis data and assists in the writing of trend-analysis reports
- Serve as back-up for QA management function
- Assist in preparation and writing of CMC sections of regulatory submissions
- Review and approve commissioning, qualification, and validation protocols and reports.
- Perform other QS activities as necessary
- Quality Metrics: Collecting, processing and reporting of quality metrics data
- Mentoring: using your experience, mentor others in QA methodologies, practices and techniques. Conduct regularly scheduled GMP training classes
- CE Mark Support: Provide support for CE Mark maintenance
- Flexible work schedule to overlap with Sr. Manager to provide maximum QA coverage for manufacturing activities
- Occasional weekend work may be necessary
- Overnight travel (5 – 10%) may be required for auditing, training, client meetings, etc.
- Bachelor’s Degree in Life Sciences, Chemistry, Engineering or closely related scientific discipline
- Minimum 5 years of practical Quality System experience in a regulated pharmaceutical or biologics environment
- High-level of proficiency with MS Office applications i.e. Outlook, Excel, Word, PowerPoint, Project, and Visio.
- Strong technical writing skills
- ASQ Certification, CQE, CQA, RAPS, compliance - related certificates, or clearly documented equivalence by experience and training
- Strong statistical methods aptitude
- Experience with Electronic Document Management Systems (EDMS), e.g., Trackwise, Master Control, Agile, etc.
- Participate with Drug Master Files and eCTD submissions
- Experience working in a Contract Manufacturing Organization (CMO) environment