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Manufacturing Specialist
CINCO Engineering. Support execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in manufacturing operations and quality systems, with a strong focus on Change Control processes, process validation, and compliance. Capable of leading cross-functional teams and driving process improvements while effectively communicating with stakeholders.
Highest-signal resume keywords
Change Control ExpertiseProcess ValidationManufacturing Operations ExperienceTrackWise ProficiencySAP Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process ImprovementTroubleshootingCAPA ManagementRisk AssessmentDocument Management
Soft Skills
Effective CommunicationCollaborationCritical ThinkingResults-Driven
Tools & Technologies
TrackWiseSAP
Industry Keywords
Manufacturing SystemsQuality SystemsNon-ConformanceProcess MonitoringNew Product Introductions
About the role
Key responsibilities & impact- Support execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions
- Apply process, operational, scientific, compliance, analytical, and troubleshooting expertise to support manufacturing operations
- Serve as primary production process owner for process support systems and assist with ownership of more complex process systems
- Serve as External Supply Quality Record Owner for supplier-related Change Control quality records
- Lead cross-functional meetings to progress and close Change Control records
- Initiate, revise, and approve manufacturing procedures
- Ensure procedures reflect current operations
- Serve as a document owner
- Assess process performance through floor observation and performance-data review
- Evaluate, plan, and implement process improvement solutions
- Provide troubleshooting support
- Generate training materials and assist with technical training
- Support process monitoring parameters and control limits
- Collect process-monitoring data and support deviation assessments
- Support timely execution of quarterly process-monitoring reports
- Triage non-conformances within established goals
- Author investigation reports, execute corrective actions, and manage NC/CAPA closure
- Monitor and communicate incident trends
- Review equipment/system root-cause analyses and support trend evaluations
- Assist with process-validation protocols and reports and execute process validation
- Support collection and analysis of process-validation data
- Participate in regulatory inspections, New Product Introductions, and process or equipment modifications
- Assess requirements for NPI documentation, materials, training, and equipment modifications
- Assess, prioritize, justify, and provide implementation and project-management support for process or equipment modifications
- Assist the manufacturing change owner on CCRB packages impacting the process
Requirements
What you’ll need- Minimal supervision while supporting manufacturing and quality systems
- Knowledge of CAPAs, CC, Risk Assessments, and CDOC editor
- Strong expertise in Change Control processes
- Critical-thinking skills for assessing supplier-related quality records
- Hands-on experience with TrackWise and SAP
- Effective communication and collaboration skills
- Ability to drive results across multiple stakeholders
- Doctorate; or Master's degree with 2 years of Manufacturing Operations experience; or bachelor's degree with 4 years of Manufacturing Operations experience; or associate's degree with 8 years of Manufacturing Operations experience; or High school/GED with 10 years of Manufacturing Operations experience