Quality Control Associate at OrganaBio, LLC – Miami, Florida

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.

POSITION SUMMARY

As a Quality Control Associate you will play a key role in executing quality control processes and testing to support research grade and GMP products. You will also support initiatives to improve quality systems and bioassay method qualification, validation, verification, and tech transfer to GMP facility. This position will ensure that products are tested under GLP and GMP practices.

Reasonable Accommodations Statement

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Essential Functions:

• Follow standard operating and testing procedures for product release including execute final product and in process testing, sending samples for external testing, and managing incoming data for certificate of analysis reporting.
• Execute quality control processes, standard testing protocols and coordinate with external testing laboratories to generate and report data for product lot release.
• Support quality processes such as CAPA, Change Control, stability testing, and technical investigations.
• Support the development and qualification of product characterization test methods.
• Participate in QC lab management activities such as inventory control, equipment management and calibration.
• Complete and review controlled documents (e.g., batch records and test records) in compliance with standard operating procedures, GDP and GMP guidelines.

Non-Essential Functions:

• Other related duties as assigned.
• Filing
• Data Entry
• Writing Standard Operating Procedures

POSITION QUALIFICATIONS

Competencies:

• Relevant technical proficiencies (primary cell culture, cell-based performance assays, flow cytometry, qPCR, ELISA, westerns, etc.) and track record of troubleshooting in the laboratory.
• Working knowledge of cGMP guidelines, specifically GDP and Data Integrity requirements.
• Ability to follow instructions and adhere to written protocols and procedures.
• Ability to work in a fast-paced and dynamic startup environment.
• Maintain honesty, integrity, and an excellent work ethic.
• Excellent interpersonal, organizational, communication and listening skills.

SKILLS & ABILITIES

Education: Degree (M.S/ or B.S) in a relevant technical discipline (e.g. Biology / Chemistry / Microbiology / Engineering or related field).

Experience:

• 2+ years’ experience industrial cell therapy or biotechnology experience.
• Experience with quality control processes and activities to support biotechnology products or laboratories.
• Basic biotech laboratory skills such as: pipetting, aseptic technique, cell culture, flow cytometry, qPCR, ELISA, etc.
• Experience with quality control processes related to biotechnology products or laboratories a plus.
• Working knowledge of cGMP guidelines, specifically GDP and Data Integrity requirements preferred.
• Experience with electronic quality systems such as eQMS, ELN, or LIMS preferred
• Experience communicating technical concepts and summarizing data analysis for cross functional audiences.
• Experience with technical writing for analytical reports, protocols, and batch records is preferred.
• Quality systems experience implementing and maintaining processes to comply with cGMP guidelines is highly desirable. Candidates with strong Quality Control experience relevant to cell therapy may be considered commensurate with educational background.

Computer Skills:

• Proficient in Microsoft Office products
• Knowledge of or ability to quickly learn electronic quality systems such as eQMS, ELN, or LIMS