6386 - Technical Specialist / Data Analyst

2 hours, 26 minutes ago
Full-time
Mid Level
Data Science and Analytics
Verista

Verista

Verista provides transformative compliance, automation, validation, and packaging solutions for the life sciences, pharmaceutical, and manufacturing industries, ensuring consistent, safe, and high-quality results every time.

Pharmaceuticals
251-1K
Founded 2020

Description

  • Coordinate and manage combination product change control records for product and manufacturing process changes.
  • Initiate, route, and close change records for drug-device combination product design and development, including design control documentation.
  • Manage implementation of changes across multiple manufacturing sites and track change record closures.
  • Coordinate post-market surveillance reports and update risk management files.
  • Collate surveillance information into annual reports and generate yearly risk summaries.
  • Support complaint investigations and related documentation.
  • Act as a central liaison between cross-functional teams to help ensure supply continuity.
  • Work with team members, vendors, suppliers, and contract manufacturers to coordinate changes.

Requirements

  • 3–5 years of relevant experience in a related field.
  • Bachelor’s degree (BS or BA) required.
  • Experience with medical device development and/or pharmaceutical operations in a cGMP environment is required.
  • Understanding of change controls in a regulated industry.
  • Working knowledge of US, EU, and international medical device and pharmaceutical regulations.
  • Experience with project management.
  • Experience with Veeva Vault.
  • Strong organizational and time management skills.
  • Ability to collaborate with team members, vendors, suppliers, and contract manufacturers to coordinate changes.

Benefits

  • Competitive pay with a US salary range of $85,000 to $145,300.
  • Performance-based incentive programs.
  • Company-paid Life, Short-Term Disability, and Long-Term Disability insurance.
  • Medical, dental, and vision insurance.
  • Health Savings Account, FSA, DCARE, and commuter benefits.
  • 401(k) retirement plan with employer matching.
  • Paid time off with rollover option, holidays, and as-needed sick time.
  • Tuition reimbursement and paid parental leave.

Interested in this position?

Apply directly on the company website

Apply Now

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