R&D Data Reviewer & Documentation Lead

Transpire Bio Inc.; Florida; On-site; USD 85,000 - 115,000; Full time

Job summary

Transpire Bio Inc. in New York is seeking a QA/Data integrity professional to lead data verification, document management, and SOP-compliant practices within an R&D setting.

You will review technical documents, draft summary reports, and prepare visual data representations from laboratory work. The role requires at least 3 years in a cGMP environment, proficiency with analytical methods (HPLC/UPLC, UV-Vis, GC), and strong English communication.

Qualifications

• BS degree in chemistry, chemical engineering, pharmacy, or forensic sciences or related field.
• 3+ years in a cGMP-regulated environment in the relevant discipline.
• Familiarity with analytical methods and lab practices including HPLC/UPLC, UV-Vis, GC.
• Familiarity with lab equipment and document management systems is a plus.
• Strong organizational skills and ability to manage multiple deadlines.
• Proficiency in Microsoft Excel, Word, and PowerPoint; excellent written and verbal English.

Responsibilities

• Lead organization, maintenance, and control of documentation and records for R&D product development activities.
• Responsible for technical review of documents, data verification, and preparation of reports and visual summaries.
• Ensure data integrity and accuracy of documents and data prior to submission of R&D data records to QA for review and release.
• Maintain and upload R&D documents in document management systems.
• Coordinate routine project activities, documentation, materials, and communications with internal teams and external partners.
• Participate in meetings, maintain accurate records, and follow up on assigned actions.
• Support project timelines and contribute to team objectives.
• Build and maintain effective working relationships with cross-functional colleagues and external partners.
• Perform other duties as assigned and comply with company policies and quality requirements.

Skills

Data verification

Documentation review

SOP compliance

Project coordination

Office suite

English communication

Education

BS in chemistry/chemical engineering/pharmacy/forensic sciences or related

Tools

HPLC/UPLC

UV-Vis

GC

Job description

Conducts data review and data integrity verification prior to submission of R&D data records to QA for review and release. Leads data verification, documentation review, drafts summary reports, and drafts visualization of data from the laboratories. Maintains and uploads R&D documents in document management systems. Conducts activities following Standard Operating Procedures (SOPs). Assures that Technical and Quality standards are met .

Essential Duties and Responsibilities

• Lead the organization, maintenance, and control of documentation and records for R&D product development activities.
• Responsible for technical review of documents, data verification, and preparation of reports and visual summaries.
• Responsible for ensuring data integrity and accuracy of documents and data prior to submission of R&D data records to QA for review and release.
• Maintain and upload R&D documents in document management systems.
• Coordinate routine project activities, documentation, materials, and communications with internal teams and external partners.
• Participate in meetings, maintain accurate records, and follow up on assigned actions.
• Support project timelines and contribute proactively to team objectives.
• Build and maintain effective working relationships with cross-functional colleagues and external partners.
• Perform other duties as assigned and comply with all applicable company policies, procedures, and quality requirements.

Qualifications

• BS Degree preferably in chemistry, chemical engineering, pharmacy, forensic sciences or related fields.
• 3+ years of work experience in cGMP regulated environment in the relevant discipline is a must to have.
• Familiarity with analytical methodology, laboratory practices, wet-chemistry, equipment used in laboratories such as HPLC/UPLC, UV-Vis, GC etc.
• Familiarity with manufacturing or manufacturing process equipment used in laboratories such as liquid manufacturing equipment, powder blender etc. is a plus.
• Strong organizational skills, with the ability to manage multiple priorities and deadlines in a fast-paced environment.
• Proficiency in Microsoft Excel, Word, and PowerPoint, is a must to have.
• Experience with document management systems is a plus.
• Experience with statistical analysis applications in a plus.
• Written and verbal communication skills in English is a must to have.

Are you authorized to work in the United States? Are you authorized to work in the United States?

Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)? Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)?