Quality Control (QC) Technician

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Location

Reports To

Job Overview

Essential Duties & Responsibilities

• Performs analytical testing of incoming materials and components according to approved test methods and specifications.
• Performs incoming material sampling and visual inspection.
• Executes protocols for stability testing and similar studies.
• Operates laboratory instruments and equipment such as Roche Cobas e411 immunoanalyzer, vortex mixer, bench top lyophilizer, and centrifuge.
• Performs tests including pH, conductivity, density, viscosity, and moisture (bench top lyophilizer).
• Performs instrument troubleshooting to address and resolve unexpected performance or results obtained.
• Documents laboratory activity performed according to good laboratory practices (GLP) and good documentation practices (GDocP).
• Completes laboratory testing related sections of the batch record and associated production records.
• Supports the verification and maintenance of laboratory records.
• Performs routine maintenance and calibration of laboratory instrumentation.
• Monitors laboratory consumables stock for routine testing activities.
• Schedules service calls for instrumentation and guides third party technicians during service.
• Participates in the investigation of out of specification (OOS) test results, including the determination of root cause and implementation of corrective actions.
• Anticipates and communicates issues with laboratory procedures and participates in team discussions to resolve them.
• Participates in third party audits or inspections to demonstrate testing or laboratory related activities.
• Participates in the creation, revision, and implementation of QC procedures, forms, and work instructions to improve current processes.
• Completes and maintains up-to-date employee training for all activities performed.
• Supports assigned quality assurance (QA) related activities during periods of downtime
• All other duties as assigned

• Interacts frequently with coworkers and management in Quality Assurance, Manufacturing, and Research and Development (R&D).
• Collaboration is expected to resolve testing and instrumentation issues.
• Interacts with third party instrument service providers.
• Does not have direct reports.

Work Environment / Physical Requirements:

• Ability to operate a computer and software driven lab equipment throughout the day.
• Primary activities are performed in the laboratory. Some activities are performed at a desk and include use of standard office equipment (computer, phone, photocopier, filing cabinets, etc.).
• May include periods of walking, standing, sitting, and light lifting.
• Offices are accessible by elevator but should be able to climb stairs if needed.
• Requires personal protective equipment (PPE) when working in the laboratory.
• Position is on site and does not require employee travel.
• Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples).
• General office and HVAC noise.