Quality Control (QC) Technician

Title

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

Qualifications

• Bachelor’s degree in a scientific discipline such as chemistry, biology, or engineering
• • 2 years of experience in a QC or laboratory role within a US FDA regulated industry such as medical device or pharmaceutical manufacturing
• Knowledge of and experience with Quality Management Systems (QMS) such as 21 CFR 820, ISO13485, or EU IVDR
• Knowledge and experience with current good manufacturing practices (cGMP), good documentation practices (GDocP), and good laboratory practices (GLP)
• Excellent record keeping skills and ability to follow detailed procedures
• Excellent verbal and written communication skills
• Computer proficiency with Microsoft Office products

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

Physical Requirements/Working Conditions/Equipment used:

• Ability to operate a computer and other technology related lab equipment through course of 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 or light lifting
• Offices reachable 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

Other Requirements

• COVID-19 vaccination is recommended