Associate Scientist, Data Reviewer

Transpire Bio Inc.

Town of Florida (NY)

On-site

USD 85,000 - 115,000

Full time

1 hour ago
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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.
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