Overview
Validation Specialist IV Jobs in Portsmouth, New Hampshire, USA at HireTalent
Job Title: Analytical Validation Specialist IV
Job Location: Portsmouth, NH
Job Duration: 9 months of Contract on W2
Job Summary:
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 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 and manuals and devise validation plans.
Procurement of Analytical Equipment, which includes ensuring the system meets specifications, quotes, budgets, and installations.
Analytical Equipment Ownership.
Identify Quality Issues, involve stakeholders, and drive to completion/resolution.
Participate in Risk Assessments.
Review/Approve Commissioning Qualification Validation Documents.
Perform other duties as assigned.
Education:
High School Diploma or Equivalent
Bachelor of Science preferred (4-year degree strongly preferred)
Skills:
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 (Track Wise) 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 the implementation of new equipment.
Demonstrated ability to manage medium to large-sized projects within required time frames.
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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Title: Validation Specialist IV
Company: HireTalent
Location: Portsmouth, New Hampshire, USA
Category: Quality Assurance – QA/QC, Engineering
