Computer Systems Validation (Analytical Equipment), Specialist IV
US - Portsmouth, NH, United States
USD 83K-111K (estimate) Mid-level Full Time
Tasks
- Author and maintain validation plans reports master plans
- Conduct ERES data integrity and audit trail risk assessments
- Drive gap remediation with deviations and CAPA
- Execute validation maintenance and periodic reviews
- Lead end-to-end validation for analytical equipment
- Manage computer system validation assessments
- Mentor junior specialists and ensure quality record closure
- Review and approve technical protocols IQ OQ PQ
Perks/Benefits
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | Audit Trail | Audit Trail Risk Assessment | CAPA | CFR Part 11 | CGMP | Computer system | Computer system validation | Data Integrity | Data Integrity Risk Assessment | Deviations | ERS Risk Assessment | Electronic Audit Trail | GAMP | IQ/OQ | IQ/OQ/PQ | IQ/OQ/PQ protocols | OQ PQ | Part 11 | Risk Assessment | System validation | TrackWise
Education
Regions
Countries
States
Related jobs
-
Global Sales Analytics Specialist USD 78K-102KCRM | Data Analysis | Data Integrity | ERP | Microsoft ExcelRemote workMid-level Full TimeMinnesota, United States R1d ago
-
Mid-level Full TimeFort Myers, FL, 33966, US7d ago
-
Senior HR Analytics & Systems Support Specialist USD 110K-130KAccess Control | Complex formulas | Dashboards | Data Extracts | Data GovernanceSenior-level Full TimePA-West Chester - Dunwoody Dr, United …7d ago
-
Audit Reporting and Analytics Senior Associate USD 115K-140KAdvanced Analytics | Archer | Audit Reporting | Automation | ComplianceHealth insurance | Hybrid work model | Life insurance | Paid time off | Personal/family care leaveSenior-level Full TimeJersey City, NJ, United States R9d ago
-
SME AI Governance Specialist USD 131K-237KAI Governance | AI/ML | AI/ML Lifecycle Management | AI/ML lifecycle | API DesignSenior-level Full Time1887 Alexandria VA, United States9d ago
-
SME AI Governance Specialist USD 131K-237KA2A | AI Governance | AI/ML | AI/ML Model Evaluation | API DesignLight travelSenior-level Full Time6314 Remote/Teleworker US, United States R9d ago
-
Data Quality Specialist- Oncology USD 54K-72KCoding | Confidentiality | DBase) | Data Analysis | Data IntegrityMid-level Full TimeMary Babb Randolph Cancer Center, United …15d ago
-
AI transparency | Algorithm Governance | Algorithmic Fairness | Artificial Intelligence | Audit toolingMid-level Full TimeSan Jose, California, United States16d ago
-
Quality Specialist, Fulfillment USD 38K-38K21 CFR | 21 CFR 210 | 21 CFR 211 | Audit trails | CAPAOnsite workEntry-level Full TimeLongview-TX Fulfillment Center, United States20d ago
-
Environmental regulations | Health and Safety | ISO 13849 | Machinery safety | Occupational health401k plan | Maternity leave | Medical, dental & vision coverage | Paid time off | Parental leave optionsMid-level Full TimeNorth Reading, Massachusetts, USA21d ago
-
BAFO Business Analytics Specialist USD 73K-99KAudit Readiness | Compliance tracking | Contract Monitoring | Cost Allocation | Data AnalysisSenior-level Full TimeState Office Medicaid / LaCHIP, United …22d ago
-
API | Backup and Recovery | Cloud Computing | Complex event processing | Data BackupSenior-level Full TimeWashington Metropolitan Area, VA / MD, …23d ago
-
Data Science Specialist USD 75K-80KAutomation workflows | Curriculum Data Management | Dashboard Development | Data Discrepancy Analysis | Data IntegrityEmployee awards | Great Place to Work certification | Health and welfare plans | Referral bonus | Training and developmentEntry-level Full TimePensacola, FL27d ago
-
Sr. Product Specialist, Analytics & Machine Learning USD 137K-233KAsset allocation | Azure | Data Engineering | Data Quality | DatabricksSenior-level Full TimeChicago, IL, United States27d ago
-
Credit Products Loan Fulfillment Specialist USD 46K-57KAnti-Money Laundering | Bank Secrecy Act | Bank secrecy | Beneficial ownership | Commercial credit401k company match | Disability benefits | Employee assistance program | Employee volunteer program | Flexible spending accountMid-level Full TimeHoover, AL - Riverchase North Building …27d ago
-
Data Governance Specialist II USD 66K-108KData Compliance | Data Dictionary | Data Governance | Data Integrity | Data QualityNon profit mission driven organization | Remote work flexibility | Training and development | Travel up to 50 percentMid-level Full TimeCHSGa IT - Macon, United States29d ago
-
Business Continuity | Business Continuity Planning | Business Impact Analysis | Business impact | Cloud PlatformsCareer growth opportunities | Hybrid work schedule | Subsidized educationMid-level Full TimeSan Francisco, CA, United States1mo ago
-
Analytical Skills | Anti-Money Laundering | Bank Secrecy Act | Bank secrecy | Beneficial ownership401k company match | Disability benefits | Employee assistance program | Employee volunteer program | Flexible spending accountMid-level Full TimeHoover, AL - Riverchase North Building …1mo ago
-
Enrollment and Operations Specialist USD 56K-65KCRM | Compliance reporting | Customer Relationship Management | Customer relationship | Data IntegrityMid-level Full TimeRooted School Indianapolis1mo ago