Associate Scientist, Data Reviewer
Transpire BIO Inc. Weston, Florida, United States
Biotechnology Research · 51-200 employees
Applying here? Try the free cover letter tool — paste this posting and your résumé, no account needed.
About the role
Reviews R&D data and documentation for accuracy and integrity before submission to QA, and prepares reports and visual summaries. Maintains records in document management systems and coordinates project activities, communications, and follow-up with internal teams and external partners.
What they look for
Requirements
Requires a bachelor's degree, preferably in chemistry, chemical engineering, pharmacy, forensic sciences, or a related field, and at least three years of relevant experience in a cGMP-regulated environment. Candidates should have familiarity with analytical laboratory methods and equipment, strong organizational and communication skills, and proficiency in Microsoft Office; document management and statistical analysis experience are advantageous.
Full description
Job Summary
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.
