3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow replacement of each individual patient’s parts with tissues designed and created specifically for them. 3DBio has developed unique capabilities toward the creation of living tissue implants for therapeutic applications. The technology platforms include a full suite of features to meet the FDA’s requirements for therapeutic manufacturing, including novel and proprietary: 3D-bioprinter (GMPrint™), bio-ink (ColVivo™), and cell processes. In pre-clinical studies the platform has demonstrated the ability to generate functioning living tissues.
The Quality Assurance Specialist develops, establishes and maintains Document Control methodologies, systems and practices which meet the applicable regulatory requirements and 3DBio procedures. Serves as a Quality representative to improve Document Control, Training, Investigations and Good Documentation Practices awareness of the regulatory and 3DBio requirements to the different functional areas. Communicates quality initiatives in support of departmental, functional quality goals and priorities. Provides Document Control, Training support to the Quality and R&D teams, as needed. Administers any applicable company investigation systems (ex. CAPA, OOS, Deviations). This is a hands-on, non-supervisory position.
- Champions Document Control, Investigations, and Training initiatives at 3DBio.
- Authors, revises, reviews, formats 3DBio documentation in compliance with company procedures and the applicable regulatory requirements and standards.
- Manages and maintains the Document Control and Training system at 3DBio that includes but it is not limited to the organization, issuance, maintenance, archiving, and retirement of documents.
- Maintains internal and external libraries at 3DBio documentation and is the primary liaison with external libraries subcontractors.
- Ensures that all documentation is controlled and current.
- Ensures that all employee training is conducted and documented in compliance with all the applicable 3DBio procedures.
- Generates applicable training materials that include but it is not limited to Document Controls, Training, Investigations, and GDPs, as needed and as defined in the 3DBio procedures. Conducts related training on a periodic basis and as needed.
- Provides guidance and support to teams in generating applicable documentation.
- Proactively investigates document control issues, identifies improvements, and implements good documentation practices at 3DBio.
- Ensures that all applicable Quality requirements are met at all stages of the product development process and manufacturing.
- Manages Employee Training documentation including the maintenance of employee training records.
- Ensures that all Laboratory Notebooks and logbooks are controlled, maintained, stored, and archived.
- Orders, issues and maintains all applicable notebooks, logbooks.
- Ensures that all documentation related to investigations is completed, maintained, and stored in compliance with the applicable system procedures.
- Ensures that all company records are maintained, stored, and archived according to company procedures and the applicable regulatory requirements and standards.
- Reviews batch records, QC documentation, deviations / non-conformances, and associated records in support of clinical batch release.
- Associate Degree required Bachelor Degree preferred.
- 2-5+ years of quality/document control experience in the pharmaceutical industry, biotech, or medical device industry.
- Working knowledge of compliance best practices for biologics and/or drug products.
- Ability to prioritize, manage time well, multitask, troubleshoot.
- Comprehensive knowledge of US Quality System Regulatory requirements.
- Ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience.
- Demonstrated success in delivery of key milestones against tight timelines.
- Aptitude to succeed in the culture of a fast-paced, start-up biotechnology company.
- Strong written and verbal communication skills.
- Technical writing skills preferred.
- Strong organizational and computer (Microsoft Word, Excel, Powerpoint, Adobe Acrobat) skills required.
- This is a full-time position based in Long Island City, NY.
- The Quality Assurance Specialist will report directly to the Head of Quality.
- No travel requirement at the current time.
- Must be able to work in a team environment and with some to minimal supervision.