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Analytical Validation Specialist IV

Portsmouth, NH 03804

Posted: 02/25/2025 Employment Type: Contract Job Category: Quality Job Number: 4304

Job Description

Analytical Validation specialist IV will lead validation activities including, but not limited to, software updates, new system introduction, and decommissioning of analytical systems. 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.

Responsibilities:
 
  • Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of analytical equipment.
  • Drive/own the validation plans and execution of analytical equipment changes and process improvements.
  • Execution of  Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
  • Own all forms of TW records including CC/CAPA/Deviations to support project completion.
  • Generating User Requirements Specification Documentation, complete Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
  • Review analytical equipment, manuals, and devise validation plans
  • Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations.
  • Analytical Equipment Ownership
  • Identify Quality Issues, involve stakeholders, drive to completion/resolution
  • Participate on Risk Assessments
  • Review/Approve Commissioning Qualification Validation Documents
  • Perform other duties as assigned

Requirements:
 
  • Bachelor of Science in Science related discipline or relevant experience in the field
  • 5-10 years of Manufacturing, QC, Validation experience
  • Advanced technical knowledge of Quality control and manufacturing operations.
  • Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations
  • Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
  • Demonstrated ability to manage medium to large sized projects within required timeframes.
  • Demonstrate ability for effective Planning, Organizing and Controlling competency
  • Demonstrate sound decision making.
  • Ability to work inter-departmentally and with customers.
  • Demonstrates role model behaviors for GMP and Safety behaviors
  • Strong written and verbal communication skills
  • Ability to work in MS Project, Word, Excel, PowerPoint
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About Portsmouth, NH

Discover exciting job opportunities in the vibrant Portsmouth, New Hampshire area today! Located on the beautiful Seacoast, Portsmouth boasts a rich history, picturesque landscapes, and a thriving arts scene. Home to iconic landmarks like the historic Strawbery Banke Museum and Prescott Park, this charming coastal city offers a unique blend of culture and opportunity for career growth. With its renowned local cuisine, diverse art galleries, live theaters, and outdoor recreation at places like Great Bay National Wildlife Refuge, Portsmouth is an enticing place for job seekers to build their careers. Explore our job listings in this enchanting region and take the next step towards a fulfilling career in Portsmouth!