CSV Analytical and Enterprise Validation Specialist

CSV Analytical and Enterprise Validation Specialist

CSV Analytical and Enterprise Validation Specialist

15 hours ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Job Title : CSV Analytical and Enterprise Validation Specialist IV

Duration : 12+ Months Contract with possible extension

Location : Portsmouth, NH

Job Description

• CSV, Analytical and Enterprise Validation specialist IV will lead validation activities including, but not limited to, software updates, new system introduction, Administration of systems and applications, and decommissioning activities as appropriate. This person will work closely with other functional groups like Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to support updates to help the site remain in compliance and contribute to quality, on-time delivery and right first-time performance.
• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of CSV, analytical and enterprise systems / applications.
• Review and Approval of Installation Qualifications / Operational Qualifications and drafting Performance Qualifications as required.
• Assist in generating User Requirements Specification Documentation, Electronic Records / Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
• Prepare Administration and Configuration specification document with support from vendor user manual.
• Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations.
• Performs user and application software administration on Enterprise systems. Works on troubleshooting assignments that are complex in nature where considerable judgment and initiative are required in making creative and effective recommendations to solve problems.
• Create and or Revise SOPs for CSV, Analytical and enterprise systems and applications.
• Participate on Risk Assessments
• Review / Approve Commissioning Qualification Validation Documents
• Perform other duties as assigned.

Education

Experience

TB_PH

Job # : 25-31298

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Contract

Job function

Job function

Quality Assurance

Industries

Staffing and Recruiting

Referrals increase your chances of interviewing at TalentBurst, an Inc 5000 company by 2x

Get notified about new Validation Specialist jobs in Portsmouth, NH

CSV Analytical and Enterprise Validation Specialist

CSV Analytical and Enterprise Validation Specialist

Portsmouth, NH $60.00-$65.00 30 minutes ago

CSV Analytical and Enterprise Validation Specialist

Specialist III, Quality Assurance Operations - LSA

Computer Systems Validation Lead Engineer

Clinical Quality Specialist RN Stroke Coordinator

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

J-18808-Ljbffr