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.
Job
Description:
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
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
Information
Locations Portsmouth, New HampshirePosition Open to Anywhere in the US, but will work on-siteIndustry ManufacturingStatus OpenJob Age 5 Day'sCreated Date 04/30/2025No.of Positions 1Duration 12Zip Code
