Quality Control Technician in Denver, Colorado at STAQ Pharma Inc
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Job Description
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 escalate 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 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.
What Success Looks Like:
- Maintains accurate, organized, and traceable QC records, sample documentation, logbooks, and submission information.
- Understands that sample handling, environmental monitoring support, and documentation accuracy directly impact patient safety and product quality.
- Follows procedures carefully and asks for clarification before proceeding when information is unclear or does not match expectations.
- Communicates clearly with QC, QA, Production, Warehouse, and third-party laboratories to keep quality activities moving forward.
- Identifies and escalates quality concerns, missing documentation, sample discrepancies, or potential deviations in a timely manner.
- Balances urgency with compliance and does not sacrifice accuracy, documentation, or safety to move work faster.
- Demonstrates strong attention to detail, professionalism, reliability, and a willingness to learn within a regulated manufacturing environment.
- Supports continuous improvement by identifying opportunities to improve sample tracking, documentation flow, communication, and quality processes.
Required Qualifications:
- 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.
Physical Requirements:
- Ability to work in or around cleanroom and controlled manufacturing environments as required.
- Ability to wear required PPE and follow gowning, cleanliness, and safety procedures.
- Prolonged periods of sitting at a desk and working on a computer.
- Ability to stand, walk, bend, reach, and handle samples, materials, or documentation as needed.
- Ability to lift up to 15 pounds at times.
Work Environment:
This position supports QC activities within a 503B pharmaceutical manufacturing environment and may involve work in cleanroom, controlled, laboratory support, warehouse, and office settings. Employees are expected to follow all applicable PPE, gowning, cleanliness, documentation, safety, and quality requirements. The role requires regular interaction with production areas, quality records, samples, materials, external laboratories, and cross-functional teams.
Benefits:
We offer a comprehensive and competitive benefits package designed to support the health, well-being, and financial security of our employees and their families.
At STAQ Pharma, all full time employees have access to:
- 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
The application window for this position is anticipated to be open at least 25 days