R&D Data Reviewer & Documentation Lead

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.

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)?