Quality Technician II

Job Title: Quality Technician II

Location: 1 Becton Circle, Durham, NC 27712

Position Summary

The Quality Technician II is responsible for performing standard laboratory tests, routine experiments, and quality assessments using well-established procedures. This role supports product release, equipment qualifications, validations, process improvements, and other critical site initiatives. The individual will perform moderately complex testing assignments, exercise judgment in resolving routine issues, and prepare detailed reports with recommendations for technical problem resolution.

This position requires interaction with manufacturing, sterilization, vendors, contract test laboratories, and other internal sites. Standard tasks are performed independently, while new assignments are completed with general supervision.

Key Responsibilities

Environmental Monitoring

• Conduct routine assessments of air, water, and surfaces to detect potential contamination risks.
• Document and escalate deviations to maintain aseptic and controlled environments.

Quality Control Testing

• Perform laboratory testing on components and finished goods per testing schedules and specifications.
• Conduct assays including:
• Total Organic Carbon (TOC)
• Gram staining
• Growth promotion
• Particulate count
• Bioburden
• Sterility testing
• Endotoxin testing
• Cell-based assays
• Other biological and chemistry-based tests
• Review results for accuracy and compliance.
• Support investigations, nonconformance analysis, and corrective actions with “right-first-time” execution.

Sample & Inventory Management

• Manage sample distribution, tracking, and documentation within laboratory systems.
• Monitor and order lab supplies, reagents, and consumables to ensure uninterrupted operations.

Data Entry & Documentation

• Accurately enter test results, observations, and lab activities into data management systems.
• Maintain complete, timely, and compliant records per regulatory and internal quality standards.

Laboratory Maintenance

• Assist with general laboratory upkeep including:
• Routine cleaning
• Glassware washing
• Autoclaving
• Ensure lab spaces are organized, compliant, and inspection-ready.

Validations & Qualifications

• Perform assay validations, equipment qualifications, and special projects under general supervision.
• Support implementation and revisions of SOPs, identifying workflow inefficiencies and proposing improvements.

Collaboration & Leadership

• Work closely with the Laboratory Supervisor to address technical problems and anticipate operational challenges.
• Coordinate testing assignments and contribute to daily workflow planning.
• Train new personnel following established training protocols.
• Perform additional duties as assigned to support lab and quality operations.

Qualifications

Education & Experience

• Bachelor’s degree in a scientific or technical discipline preferred (e.g., Biology, Microbiology, Chemistry, Biochemistry, Biotechnology).
• 2–4 years of experience in a laboratory, quality control, or GMP-regulated environment preferred.
• Equivalent combination of education and hands-on lab experience may be considered.

Required Skills

• Strong understanding of laboratory practices, aseptic techniques, and quality principles.
• Proficiency in executing biological and chemistry assays.
• Ability to interpret technical data and follow strict procedures.
• Experience in GMP/GDP documentation and data entry.
• Strong problem-solving and critical-thinking ability.
• Ability to work independently with minimal supervision.
• Excellent communication, organization, and time-management skills.

Preferred Skills

• Experience in FDA, ISO, or other regulated environments.
• Familiarity with LIMS or electronic data management systems.
• Previous experience performing environmental monitoring or sterility assurance.
• Knowledge of equipment qualifications and assay validation.