Responsible for performing quality inspections and in-process controls to ensure products meet established specifications, regulatory requirements, and quality standards. Supports manufacturing operations through effective sampling, inspection, documentation, and timely escalation of quality issues.
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Quality Control & In-Process Activities
- Perform in-process inspection and sampling activities per approved procedures, specifications, and sampling plans
- Ensure proper handling and traceability of samples throughout inspection and testing
Compliance & Documentation
- Ensure strict adherence to Good Documentation Practices (GDP) - accurate, complete, legible, contemporaneous records
- Comply with GMP, company policies, and applicable regulatory requirements
- Execute all activities per approved SOPs, Work Instructions, and quality standards
Deviation Management & Escalation
- Identify, document, and escalate non-conformances, abnormal conditions, or deviations via appropriate quality systems (NCRs/QNs)
- Escalate conditions not meeting requirements immediately or within defined timelines
- Provide real-time feedback to operations to support containment and corrective actions
Support to Quality Systems
- Support investigations by providing accurate data, traceability, and objective evidence
- Maintain quality records
- Support internal/external audits and audit readiness activities
Safety & Compliance
- Demonstrate compliance with safety programs and site safety goals
- Maintain required training/certifications (GMP, safety)
- Perform other duties as assigned to support business needs
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Experience with measurement and inspection equipment
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- Knowledge of cGMP requirements and regulatory standards
- Understanding of SOPs, Work Instructions, and quality systems
- Strong attention to detail and documentation accuracy
- Identifying and escalating quality issues effectively