Job Description
Job Description
Job Description:
The Analytical Validation Specialist IV will lead validation activities including software updates, new system introductions, and the decommissioning of analytical systems. This role will work cross-functionally with Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to ensure ongoing compliance, timely project delivery, and operational excellence.
Contract role from May 2025 to May 2026.
Key Responsibilities
- Serve as the Subject Matter Expert (SME) for analytical equipment in Quality Control, Manufacturing, and related departmentssupporting design, operations, and troubleshooting.
- Lead the creation and execution of Validation Plans for analytical equipment changes and process improvements.
- Conduct Installation Qualifications (IQ) and Operational Qualifications (OQ), and draft Performance Qualifications (PQ) as needed.
- Own and manage all Technical Writing (TW) records, including Change Controls (CC), Corrective and Preventive Actions (CAPA), and Deviations.
- Generate critical documentation, including User Requirement Specifications (URS), Data Integrity Risk Assessments, and Audit Trail Reviews.
- Review equipment manuals and develop equipment-specific Validation Plans.
- Manage procurement of analytical equipment, ensuring systems meet specifications, budgets, and installation criteria.
- Act as Analytical Equipment Owner throughout the lifecycle.
- Identify and resolve Quality Issues in collaboration with key stakeholders.
- Participate in Risk Assessments to support process and equipment validation.
- Review and approve Commissioning, Qualification, and Validation (CQV) documentation.
- Perform additional duties as assigned.
Qualifications & Competencies
- Advanced technical knowledge in Quality Control and manufacturing operations.
- Proficiency in Quality Systems, including deviations, CAPAs, change controls, and OOTs (TrackWise system preferred).
- Working knowledge of process, equipment, cleaning, and computer system validationsable to critically review and approve protocols and reports.
- Proven ability to manage medium-to-large projects on time and within scope.
- Strong planning, organizational, and decision-making skills.
- Excellent interpersonal skills; able to work cross-functionally and with external clients or auditors.
- Demonstrated GMP and Safety compliance in previous roles.
- Excellent written and verbal communication skills.
- Proficiency in MS Project, Word, Excel, and PowerPoint.
$ 47.42/hr
Prof23