Quality Control Technician

STAQ Pharma Inc • Denver, CO

3d • Hybrid

About The Position

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.

Requirements

• Associate degree in the sciences or equivalent experience preferred.
• At least 1 year of Quality Control Technician experience preferred.
• Pharmaceutical, medical device, biotechnology, laboratory, sterile manufacturing, or regulated manufacturing experience preferred.
• Familiarity with cGMP, GDP, FDA-regulated environments, quality documentation, or controlled procedures preferred.
• Strong attention to detail and ability to review records, forms, and logs for completeness and accuracy.
• Excellent written, verbal, interpersonal, and independent judgment skills.
• Ability to work in a fast-paced environment with changing priorities, competing deadlines, and cross-functional requests.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and ability to learn vendor portals or internal quality systems.
• Must be able to speak, read, and write in English.
• Must be a team player with a professional, quality-focused, and patient-safety mindset.

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 escalate 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 assigned based on business and quality needs.

Benefits

• Medical, dental, and vision insurance options
• Employer-paid life insurance and disability coverage
• Employee Assistance Program
• 401(k) retirement plan with employer match
• Paid time off (PTO), sick leave
• 7 paid holidays
• Opportunities for professional growth in a regulated pharmaceutical manufacturing environment
• Employee-focused culture emphasizing safety, quality, and teamwork

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree