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Job Analysis:
The CSV Analyst/Technical Writer role at Verista is primarily focused on developing and maintaining GxP-compliant laboratory documentation in the pharmaceutical sector, specifically for large molecules and biologics. This position requires a deep understanding of laboratory operations and equipment validation, ensuring not only the accuracy of documents but also their compliance with regulatory standards like FDA and ICH. Successful candidates will need to interpret lab results and collaborate effectively with QC scientists to ensure clarity and precision in technical terminology. The role's responsibilities indicate a strong emphasis on cross-functional collaboration, which suggests candidates should be adept at navigating complex team dynamics. Individuals will need to exercise autonomy and sound judgment, as they will often work independently to resolve ambiguities in documentation standards while meeting tight deadlines. Within the first 6-12 months, success could be measured by the quality of documentation produced, effective collaboration with scientific teams, and the ability to support successful audits and inspections.
Company Analysis:
Verista occupies a significant space in the life sciences consultancy industry, providing comprehensive solutions that facilitate compliance and quality for clients engaged in developing healthcare innovations. The company is positioned as a leader in GxP advisory services, highlighting its credibility in dealing with some of the industry's most complex challenges. This role will likely thrive in a fast-paced and growth-oriented culture that values collaboration, client success, and continuous learning—elements that align with Verista's mission. Team members will be expected to contribute actively to collective expertise while maintaining a focus on impact and integrity. The Technical Writer function will fit within a broader organizational structure where collaboration with various teams, including QC and QA, is essential, suggesting that this role could lead to significant visibility within the company. As Verista emphasizes service excellence and team empowerment, candidates should prepare to embody these values in their work.