BioLab Holdings, Inc.
Sustaining Quality Engineer
BioLab Holdings, Inc., Arizona City, Arizona, United States, 85123
Description
Validation Strategy & Protocols:Develop, review, and execute validation strategies and protocols utilizing technical writing and ensuring they meet regulatory requirementsSupport the evaluation of validation strategies and risk assessments for new equipment or changes to existing equipmentCompliance:
Review and evaluate procedures for compliance and utilization of Good Manufacturing Practices (GMP)Assist in ensuring that testing and verification and processes adhere to GMP standards and operational best practicesRisk Management and Continuous Improvement
Conduct risk analysis for nonconformances, continuous improvement efforts, and validation activities to maintain regulatory compliance and effective product managementIdentify potential risks and work with cross-functional teams to implement solutionsProtocol Generation:
Create and support the generation of validation protocols, reports, and other documentation using clear technical writingEnsure efficient workflows for protocol development and efficient workflowsData Analysis:
Perform data collection, analysis, and review to identify trends, areas of improvement, and escalation needsLead efforts to investigate and resolve quality issues identified through data analysisProcess Control & Compliance:
Review and support test methods, inspection procedures, and other process controls to ensure compliance and identify opportunities for improvementProvide support on audits and response coordinationNonconformance & CAPA Support:
Provide support on Nonconformances, Corrective and Preventative Actions (CAPA) investigations, and ComplaintsSupport in conducting root cause analysis for quality events and investigationsTraining and Best Practices:
Provide training and guidance in manufacturing on quality-related best practices, procedures, and compliance standardsFacilitate the continuous improvement of quality practices across the organizationRequirements
Education:
Minimum Bachelor's degree, preferably in Engineering or Life SciencesExperience:
Minimum of 2-4 years of experience in a regulated industry preferably in the pharmaceutical or medical device industryStrong experience with validation planning & execution, risk assessments, and technical writingKnowledge of GMP, ISO standards, and other regulatory requirementsSkills & Competencies:
Extensive knowledge of quality systems and continuous improvement methodologiesExcellent communication skills with the ability to work collaboratively in a cross-functional environmentDetail-oriented with the ability to handle complex issues and drive solutions effectivelyProficient in technical writing, protocol development, and data and risk analysis
Validation Strategy & Protocols:Develop, review, and execute validation strategies and protocols utilizing technical writing and ensuring they meet regulatory requirementsSupport the evaluation of validation strategies and risk assessments for new equipment or changes to existing equipmentCompliance:
Review and evaluate procedures for compliance and utilization of Good Manufacturing Practices (GMP)Assist in ensuring that testing and verification and processes adhere to GMP standards and operational best practicesRisk Management and Continuous Improvement
Conduct risk analysis for nonconformances, continuous improvement efforts, and validation activities to maintain regulatory compliance and effective product managementIdentify potential risks and work with cross-functional teams to implement solutionsProtocol Generation:
Create and support the generation of validation protocols, reports, and other documentation using clear technical writingEnsure efficient workflows for protocol development and efficient workflowsData Analysis:
Perform data collection, analysis, and review to identify trends, areas of improvement, and escalation needsLead efforts to investigate and resolve quality issues identified through data analysisProcess Control & Compliance:
Review and support test methods, inspection procedures, and other process controls to ensure compliance and identify opportunities for improvementProvide support on audits and response coordinationNonconformance & CAPA Support:
Provide support on Nonconformances, Corrective and Preventative Actions (CAPA) investigations, and ComplaintsSupport in conducting root cause analysis for quality events and investigationsTraining and Best Practices:
Provide training and guidance in manufacturing on quality-related best practices, procedures, and compliance standardsFacilitate the continuous improvement of quality practices across the organizationRequirements
Education:
Minimum Bachelor's degree, preferably in Engineering or Life SciencesExperience:
Minimum of 2-4 years of experience in a regulated industry preferably in the pharmaceutical or medical device industryStrong experience with validation planning & execution, risk assessments, and technical writingKnowledge of GMP, ISO standards, and other regulatory requirementsSkills & Competencies:
Extensive knowledge of quality systems and continuous improvement methodologiesExcellent communication skills with the ability to work collaboratively in a cross-functional environmentDetail-oriented with the ability to handle complex issues and drive solutions effectivelyProficient in technical writing, protocol development, and data and risk analysis