HireTalent
Validation Specialist IV
PayCompetitive
LocationPortsmouth/New Hampshire
Employment typeContract
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Job Description
- Req#: 25-11570
Job Title: Validation Specialist IV
Job Location: Portsmouth, NH
Job Duration: 12 months on W2
Job Description:
The Analytical Validation Specialist III will assist validation activities including, but not limited to, software updates, new system introduction, and decommissioning of analytical systems.
The individual will work closely with Senior Analytical Validation Specialists and other functional groups to contribute to quality, and right first time performance.
This role requires closer support from other Subject Matter Experts and Management.
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.
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 (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, PowerPointAbout the company
HireTalent is an executive search firm and temporary staffing solutions provider that specializes in providing direct-hire, contract-to-hire, MSP staffing, Vendor Neutral Program staffing, and consulting services to clients at a national level.