QC Analyst II

OrganaBio 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, OrganaBio 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 OrganaBio subsidiary Excellos Labs, LLC ("Excellos Labs") located in Downtown San Diego, California.

JOB SUMMARY

The Quality Control Analyst will be an integral part of the QC Lab startup and implementation and perform and QC testing for Excellos Labs. The QC Analyst role requires cGMP testing according to established procedures, contributions to assay and equipment validations, data analysis and maintaining records, reports and data as required. The Analyst will participate in departmental meetings and educational programs as well as support the Excellos Labs safety, GMP and Quality plans. In addition, the Analyst will have the opportunity to assist with continuous improvement of systems to support a growing company.


RESPONSIBILITIES
• Execute cGMP testing for cell therapy products.
• Comprehensive knowledge of current Good Manufacturing Practices (cGMP), related to Quality Control operations and testing.
• Adheres to Good Documentation Practices to maintain comprehensive testing, equipment, and sample management records.
• Assist with validation and implementation of novel testing methods.
• Collaborates with area managers to ensure accuracy and adherence to production schedules.
• Assist with sample submission to contract laboratories.
• Proactively identifies and assesses operational risks, communicates issues to senior management and cross-functional support teams.
• Experience in Cell Therapy GMP areas: QC testing Laboratories (preferred), Manufacturing, and Process Development.
• Proficiency in flow cytometry, cell counting, sterility and potency methods.
• Data analysis, review and approval of QC assays and contract lab testing documentation.
• Assist with generation of Certificates of Analysis.
• Experienced in troubleshooting, investigation, and root cause analysis in a cGMP environment.
• Using aseptic processing techniques, performs analysis of samples, and bioproduct manipulations and aliquoting in biosafety cabinets.
• Oversees the routine maintenance of lab equipment and environment.
• Maintains complete, accurate, legible, neat, organized, up-to-date records/laboratory notebooks.
• Maintains supply inventory levels, orders laboratory reagents, and supplies as needed.
• Adheres to production schedules to ensure on-time production logistics and fulfillment of client requests.
• Compiles data and prepares reports for internal use and/or external customer reporting.
• Supports generation and revision of documentation, such as SOPs, validation protocols, reports, deviations or change controls.
• Works under minimal supervision. Needs to attend to details, and investigate, review, and troubleshoot problems independently.
• Supports internal and external tech transfer efforts by participating in project teams, external client meetings, and completing deliverables to ensure on time execution of established timelines.
• Performs peer review of manufacturing and testing records.
• Provides regular updates, data, and applicable documentation for project teams.


WORKING ENVIRONMENT
• 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.

PHYSICAL REQUIREMENTS
• 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.

EQUIPMENT USED
• General Laboratory equipment (examples include but are not limited to: sterility testing equipment, incubators, water baths, centrifuges, refrigerators/freezers (includes Liquid nitrogen freezers), sterile hood, cell counter, cell isolation and analysis systems, FACs analyzer)
• Laboratory Information Management Systems or similar software


QUALIFICATIONS

Education:
• Bachelor's degree in science related field.


Experience:
• Minimum of 5 years related lab experience.
• Strong attention to detail and ability to follow written procedures.
• Laboratory experience with working knowledge of basic lab procedures.
• Previous experience with sterile technique and human biospecimens.
• Previous cGMP experience required.

Skills:
• Must be keenly detail-oriented, well-organized, self-motivated, flexible and capable of independent work with changing priorities, and display good time management skills.
• Ability to perform advanced troubleshooting of scientifically technical problems.
• Ability to adapt to new technologies.
• Interpersonal skills to establish and maintain professional relationships.
• Ability to work collaboratively as a member of a team and to communicate effectively within an interdisciplinary environment.
• Ability to work well under pressure and meet critical timelines.
• Ability to work, learn, adapt, and execute in a fast-paced commercial environment.


Hours: Monday - Friday 8am - 6pm

Salary Range: $33 - $37 per hour