Quality Control Inspector; 2nd Shift

About This Role

The 2nd Shift Quality Control (QC) Inspector supports 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.
• Verify manufacturing steps, inspections, testing reports, in‑process checks, and approvals are properly completed and documented.
• Ensure material traceability, including material lots, sub‑assemblies, equipment identification, and inspection status.
• Access and reference the eQMS to ensure current, approved revisions are used.
• Verify documentation is executed against correct released revisions and report discrepancies.
• Identify documentation errors, omissions, or discrepancies and ensure timely correction per GDP requirements.

• Perform in‑process, final, or verification inspections per approved plans.
• Ensure inspection results are accurately recorded and aligned with acceptance criteria.
• Support timely review and release readiness of manufacturing lots.

• Identify, document, and initiate NC records when inspection results, documentation, or material conditions do not meet requirements.
• Ensure nonconforming material is properly labeled, segregated, and segregated per procedure.
• Escalate quality issues to Quality Control leadership and manufacturing supervision as required.

• Enforce GDP standards across all reviewed records.
• Ensure corrections, clarifications, and late entries are performed per approved procedures.
• Support identification of recurring documentation issues and participate in corrective actions or retraining.

• Perform RI activities when required, following sampling plans, criteria, and procedures.
• Verify material identification, lot traceability, and acceptance status.
• Accurately document RI results and communicate status to manufacturing and quality teams.

• Perform all activities in compliance with ISO 13485 and internal QMS SOPs, DOPs, and work instructions.
• Maintain inspection areas and records in audit‑ready state.
• Support internal audits and regulatory inspections by providing accurate records and evidence.

• Communicate inspection results and quality concerns clearly during shift handoffs.
• Collaborate with manufacturing, QE, receiving, and first‑shift QC personnel to ensure continuity of controls.

• High School Diploma or GED required;
  Associate’s or Bachelor’s Degree in a technical or life sciences field preferred.
• 2–5 years of experience in a regulated manufacturing environment.
• Experience navigating an eQMS for reviewing released drawings, specifications, SOPs, and instructions.
• Working knowledge of GDP and controlled document execution.
• Experience reviewing batch records, travelers, routers, and inspection records.
• Ability to initiate nonconformance records per established procedures.
• Strong attention to detail, accuracy, compliance, and…