Cell Therapy Quality Assurance Specialist

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 Cell Therapy QA Specialist is responsible for supporting the production of various cellular products in a clean room manufacturing environment. The Specialist will be responsible for working in cGMP ISO7 and ISO8 manufacturing spaces and controlled, supportive laboratory and warehouse areas. The Specialist will be responsible for QA support including, but not limited to, on the floor QA support, document management, support disposition of raw materials and product, deviation/CAPA/change control approvals as well as oversight of material and product storage and distribution.

RESPONSIBILITIES

• Adheres to, and trains team members on good manufacturing practices (GMP) guidelines.

• Provides on the floor support to manufacturing team members - understands manufacturing steps per BPR and recognizes when deviations or incidents are to be documented.

• Ensure aseptic processing techniques and appropriate cleanroom behavior are followed.

• Perform room and line clearances in support of manufacturing schedule.

• Must clothe in clean room gowns to work in a clean room environment.

• Supports environmental monitoring processes defined by the facility and assists with troubleshooting.

• Have experience in writing and/or revising Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and other Quality/Compliance related documents.

• Review completed batch records for GMP compliance and completeness, compile information for disposition.

• Preparation for and management of client audits and regulatory inspections.

• Participate in corrective and preventive action teams, assist with investigation, and root cause analysis and verify that actions are implemented and effective.

• Escalate issues to management and troubleshoot and develop solutions.

• Maintains client confidentiality as required.

• Assist Subject Matter Expert (SME) with providing training for new and existing employees.

• Supports and participates in research and investigational studies, as needed.

• Provides feedback and support in drafting and implementing documents and procedures for department development/process improvement.

• Works collaboratively with internal and external cross-functional teams.

• Supports the Excellos Labs safety, GMP and Quality Plan.

• Participates in department meetings and educational programs.

• Performs other duties as assigned.

WORKING ENVIRONMENT

• 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 hazardous chemicals.

• May be working with liquid nitrogen.

• May be called on to workdays or hours other than routinely scheduled hours, work overtime hours, or potentially work through breaks, if necessary.

PHYSICAL REQUIREMENTS

• Must be able to stand long hours.

• Must be able to gown up for cleanroom work.

• Must be able to work in a warehouse environment.

• Must be able to communicate clearly.

• May be required to lift 20 pounds.

EQUIPMENT USED

• Exposed to Laboratory processing equipment (examples include, but are not limited to: centrifuges, heat sealers, sterile connecting devices, biosafety cabinets, cell counters, flow cytometers, incubators, bioreactors, cell separators).

• Normal office equipment such as: telephone, computer, cell phone, printer, copier, fax, scanner.

• General laboratory equipment (examples include, but are not limited to: barcode scanners, scales, shippers, refrigerators, freezers).

QUALIFICATIONS

Education:

o Degree in biology or related field or equivalent combination of education, training and/or experience.

Experience:

o 5+ years industry experience with in a GMP Quality or Manufacturing environment. Cell culture and aseptic processing experience preferred.

Skills:

o Must have an understanding of adherent cell culture processes.

o Aseptic technique, cleanroom gowning, and extensive knowledge of Good Manufacturing Practices (GMPs).

o Understanding of how to apply FDA, EMA and other regions in a GMP manufacturing environment.

o Experience with drafting and revising controlled documents.

o Experience in deviations, CAPA, and change control.

o Ability to perform calculations including cell concentration determination, seeding densities, % viability, weight measurements, and volume.

o Ability to identify potential equipment or process issues.

o Ability to organize information for multiple, concurrent projects.

o Interpersonal skills to establish and maintain professional relationships both internally and externally.

o Works collaboratively with internal and external cross-functional teams.

o Critical thinking, creativity, and innovative thinking.

o Detail oriented with the ability to set priorities and organize daily work requirements.

o Must be able to work both as a team member and independently, as required.

o Proficient in professional communication both written and oral, which is clear and precise.

o Must keep management informed on any compliance and/or operational issues that arise.

o Must be flexible, as production priorities, timelines, and processes can change regularly.

o Integrity and discretion – ability to maintain confidentiality.

o Ability to perform under pressure.

Certifications/Licenses:

o Biotech certificate valued, not required.

Hours: Monday - Friday 8am - 6pm

Salary Range: Range $32 - $37

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