QC Inspector; 2nd Shift

The 2nd Shift Quality Control (QC) Inspector is responsible for supporting manufacturing operations during second shift by performing inspection, documentation review, and batch release readiness activities for finished goods and sub-assemblies. This role focuses on reviewing batch records, travelers, and routers, ensuring Good Documentation Practices (GDP) compliance, identifying quality issues, and initiating nonconformances (NCs) when required.

The QC Inspector also provides Receiving Inspection (RI) support as needed to ensure material flow continuity and compliance with inspection requirements.

• Provides real-time quality oversight on second shift, ensuring batch records, travelers, and GDP compliance are verified at the time of execution rather than retrospectively.
• Enables timely identification and containment of nonconformances, reducing quality escapes, rework, and compliance risk.
• Supports on-time release readiness and uninterrupted manufacturing flow, preventing inspection and documentation backlogs into first shift.
• Strengthens audit readiness and cross-shift continuity, ensuring clear handoff and sustained control of quality issues across shifts.

• Perform detailed review of batch records and travelers for finished goods and sub-assemblies to ensure completeness, accuracy, and compliance with approved procedures.
• Verify that all required manufacturing steps, inspections, testing reports, in-process checks, and approvals are properly completed and documented.
• Ensure material traceability, including material lots, subassemblies, equipment identification (when applicable), and inspection status.
• Access and reference the electronic Quality Management System (eQMS) to ensure the current, approved revisions of drawings, specifications, procedures, and work instructions are used during inspection and batch record review activities.
• Verify that batch records, travelers, and inspection activities are executed against the correct released document revisions, and escalating discrepancies when outdated or incorrect documents are identified.
• Identify documentation errors, omissions, or discrepancies and ensure timely correction in accordance with GDP requirements.

• Perform in-process, final, or verification inspections of finished goods and sub-assemblies per approved inspection plans and work instructions.
• Ensure inspection results are accurately recorded and aligned with acceptance criteria.
• Support timely review and release readiness of manufacturing lots to maintain production flow.

• Identify, document, and initiate Nonconformance (NC) records when inspection results, documentation, or material conditions do not meet requirements.
• Ensure nonconforming material is properly identified, labeled, and segregated to prevent unintended use.
• Escalate quality issues to Quality Control leadership and Manufacturing supervision as required.

• Enforce GDP standards across all reviewed records, including batch records, travelers, routers, and inspection forms.
• Ensure corrections, clarifications, and late entries (when applicable) are performed per approved GDP procedures.
• Support identification of recurring documentation issues and participate in corrective actions or retraining as needed.

• Perform Receiving Inspection (RI) activities when required, following approved sampling plans, inspection criteria, and procedures.
• Verify material identification, lot traceability, and acceptance status.
• Accurately document RI results and communicate material status to Manufacturing and Quality teams.

• Perform all activities in compliance with ISO 13485, and internal QMS SOPs, DOP’s and work instructions.
• Maintain inspection areas and records in a state of audit readiness.
• Support internal audits and regulatory inspections by providing accurate records and inspection evidence as requested.

• Communicate inspection results, documentation issues, and open quality concerns…