Verista, Inc.
Life Science
TechnicalSpecialist/DataAnalyst
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Technical Specialist / Data Analyst at Verista, Inc.. Skills: Change control management, Product change records. Coordinate combination product change control records. Initiate change records”
Industry & Context.
What They're Looking For.
Must Have
3 – 5 years relevant experience, BS or BA, Experience with medical device development, Experience with pharmaceutical operations (cGMP environment)
What You'll Do.
Coordinate combination product change control records
Initiate change records
Initiate change records for design and development
Route change records for design and development
Close change records for design and development
Create design control documentation
Manage design control documentation
Manage implementation of changes at manufacturing sites
Manage change record closures
Coordinate post-market surveillance reports
Coordinate risk management file updates
Collate surveillance information into yearly reports
Generate annual risk summaries
Update risk management files
Support complaint investigations
Support complaint documentation
Act as central hub between cross-functional teams
Ensure supply continuity
How You'll Work.
Team & Collaboration
Cross-functional teams; Vendors; Suppliers; Contract manufacturers
Process & Methodology
Project management
Full Job Description
Description Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise Technical Specialist Responsibilities: Coordinate and manage combination product change control records – Initiate, route, and close change records for product and manufacturing process changes. Initiate, route, and close change records for the design and development of drug device combination products, including the creation and management of design control documentation. Manage implementation of changes at multiple manufacturing sites and change record closures. Coordinate post-market surveillance reports and risk management file updates – Collate surveillance information into yearly reports. Generate annual risk summaries and update risk management files. Support complaint investigations and documentation. Act as a central hub between cross-functional teams to ensure supply continuity. Knowledge & Skills: Exceptional organizational and time management s
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