Quality Control Analyst II or III - Microbiology

Organa Bio was founded in 2018 with the mission to become the hub for tissue sourcing, clinical sample processing and contract manufacturing services to support cell and gene therapy developers around the globe. At our core, we continually apply a data-driven approach with meaningful insights across our strategically located facilities to provide solutions to our clients where they need it most.

Headquartered in Miami, Florida, Organa Bio delivers products and services that span the full development lifecycle – from proprietary tissue supply chains and cellular starting materials to expert development, testing, and other support services that expedite the path to clinical translation. This position will work at the newly formed Organa Bio subsidiary Excellos Labs, LLC (“Excellos Labs”) located in Downtown San Diego, California.

Location:

onsite in San Diego, CA.

Hours:

Monday - Friday 8am - 5:30pm

The Quality Control Analyst II or III – Microbiology will be an integral part of the quality control at Excellos Labs and perform QC testing according to established EM program and procedures, assist with the end-to-end contamination control and sterility assurance practices for cell therapy onsite aseptic manufacturing processes, contribute to assay and equipment validations, data analysis and data report, and lab maintenance.

The Analyst will participate in the training programs and support the Excellos Labs safety, GxP and Quality plans. In addition, the Analyst will have the opportunity to assist with continuous improvement of systems to support a growing company.

• Execute routine and non-routine environmental monitoring including viable air sampling, surface sampling, non-viable air sampling, and personnel monitoring in ISO classified grades 5, 7, and 8 clean room cGMP environments for cell therapy manufacturing.
• Perform microbiological assays such as sterility, endotoxin, mycoplasma, gram stain, and analytical assays such as cell count, Flow Cytometry, qPCR/ddPCR, ELISA as needed.
• Adhere to production schedules and collaborate with area managers to ensure on-time production logistics and fulfillment of client requests.
• Maintain gown and certifications for all classified/controlled manufacturing areas.
• Assist with critical material qualification (e.g. growth promotion test), method transfer, method system suitability test, and method validation and verification.
• Analyze, trend, review and approve QC data and documentation including contract lab testing records; assist with generation of Certificates of Analysis as needed.
• Identify EM excursions, deviations and abnormal assay results. Perform troubleshooting, investigation, and root cause analysis with defined CAPA actions in a GxP environment.
• Perform routine equipment and laboratory cleaning as scheduled.
• Perform sample and material handling such as receiving, submission, labeling, sampling, checking, counting, and storage.
• Monitor and maintain lab equipment and inventory (Chemicals, reagents/aliquots, and supplies) and partner with management to ensure QC safety and audit readiness.
• Comply with current Good Documentation Practices and data integrity policy throughout comprehensive QC processes and documentation for EM sampling, compendial or non-compendial testing, equipment operation, and lab notebook.
• Support generation and revision of documentation, such as SOPs/Protocols, forms, change controls and technical reports.

• Work primarily in laboratory setting.
• Normal laboratory environment with biohazard precautions.
• May be exposed to blood or bodily fluids that may be capable of transmitting diseases.
• May be exposed to chemicals that may be hazardous.
• May be called on to work or attend meetings at other than routinely scheduled hours.

• Must be able to work on a computer up to 4-8 hours per day.
• Must be able to operate laboratory equipment.
• Must be able to accommodate repetitive motion such as pipetting.
• Must be able to stand for prolonged periods of time.
• Must be able to communicate clearly.
• May be required to lift up to 40 pounds.
• Must be able to gown into a ISO7 cleanroom.

• General Laboratory…