Quality Control Technician

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Full Time Denver, CO, US

Salary Range: $24.00 To $24.00 Hourly

Position Summary:

The Quality Control Technician supports the QC function in a 503B pharmaceutical manufacturing environment by helping ensure materials, samples, documentation, and environmental monitoring activities are handled in accordance with cGMP, company procedures, and applicable regulatory requirements. This role provides hands‑on support across QC, QA, and Operations, including coordinating QC sample preparation, external laboratory submissions, environmental monitoring support, retention material management, raw material and sterile supply release support, and review of GMP documentation.

The QC Technician plays an important role in patient safety by helping verify that materials, environments, samples, and records meet quality expectations before they support manufacturing or product release.

What This Role Does Day-to-Day:

In this role, the QC Technician may support incoming material review, retention sample organization, sample preparation, environmental monitoring sample coordination, third‑party laboratory submissions, biohazard waste coordination, logbook generation, GMP document review, and inspection activities for in‑process or finished product samples. Daily work may include preparing and tracking samples, verifying documentation, using vendor portals or paper submissions for external testing, reviewing room and equipment logs, assisting with investigations, and communicating quality data or concerns to department leadership.

The role requires strong attention to detail, accurate documentation, comfort working in or around cleanroom environments, and the ability to elevate issues that may impact product quality, compliance, or patient safety.

Key Responsibilities:

• Coordinate QC sample preparation and shipment/submission of samples to external laboratories for environmental monitoring, microbiological, raw material, in-process, finished product, and other required testing activities.
• Use third‑party laboratory web portals, paper submission forms, and internal tracking tools to support accurate sample submission, chain-of-custody, and follow‑up on required testing.
• Assist with environmental monitoring and microbiological sample evaluation activities, including organizing samples, reviewing forms, and escalating missing, incomplete, or questionable information.
• Maintain retention materials, including organization, tracking, storage support, and disposal when required by procedure.
• Assist with review and release support for raw materials, APIs, excipients, sterile supplies, and other incoming materials as assigned.
• Perform sampling and inspection of in‑process and finished products according to approved procedures, sampling plans, and quality expectations.
• Coordinate biohazard waste destruction activities in accordance with internal procedures and safety requirements.
• Generate, issue, organize, or maintain logbooks and controlled documents as assigned.
• Review GMP documents, including production environmental monitoring forms, room logs, equipment logs, sample forms, and related quality records for accuracy, completeness, and GDP expectations.
• Support investigations, deviations, CAPAs, and continuous improvement activities by gathering information, reviewing documentation, and helping identify appropriate corrective or preventive actions.
• Support quality management system activities, including document control, training program support, and cross‑functional quality initiatives.
• Work closely with Production, QA, QC, Warehouse, and external laboratory vendors to support timely sample flow, material review, documentation accuracy, and quality communication.
• Identify and escalation potential documentation errors, sample discrepancies, environmental monitoring concerns, material issues, or process deviations to the appropriate quality leadership.
• Follow all applicable cGMP, GDP, SOP, OSHA, FDA, and company policy requirements.
• Perform other duties as…