Quality Control Analyst/Technician (Contract)

How you’ll make an impact:

QC Analyst/Technician supports a commercial-level GMP testing laboratories for instrument and equipment maintenance. This includes supporting the scheduling, performance, and documentation of routine maintenance in the QC Lab. They will support continuous improvement of GMP systems to ensure a compliant Quality Control lab. They interface with vendors, Quality Assurance, Facilities and IT, and other cross-functional teams, as required. They have attention to detail, documentation an awareness cGMP good documentation practice. This position is on site.

About the team:

Our QC Analysts/Technicians interface with Analytical Development and Method Validation ensuring successful method transfer, Quality Assurance, IT, Facilities, and other cross-functional teams as required. They have a cGMP operational and technical background in cell biology, biochemistry, and/or molecular biology.

How you’ll spend your time:

• Compiles the equipment/instrument work orders from the asset management system
• Creates a monthly schedule for QC Lab maintenance with guidance
• Escorts equipment/instrument vendors onsite
• Requests and/or reviews equipment/instrument logbooks
• Supports the removal/return of pipets for calibration
• Performs routine review of temperature chamber data and equipment alarm monitoring
• Supports the implementation of equipment/instrument with guidance, as needed
• Review SOPs/Forms with guidance
• Initiate laboratory deviations with guidance
• Support CAPA/Continuous Improvement Initiatives Support operational systems (data integrity/control, cGMP documentation)
• Support CAPA/Continuous Improvement Initiatives

Who you are and what you’ve accomplished:

• Associates with 1+ years in a biotechnology discipline and 1+ years of experience in a cGMP/GxP
• environment is preferred
• Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
• A passion for addressing the critical unmet medical needs of patients
• Self-directed individual who is able to work with limited direction in a fast paced, goal-oriented environment