Job Summary:
The Quality Assurance Technician is responsible for performing bioanalytical quality testing in a fast-paced laboratory environment while ensuring compliance with established quality systems. This role supports product testing, documentation, CAPA activities, and continuous improvement initiatives. The position requires strong technical expertise, attention to detail, and the ability to operate with minimal supervision while serving as a subject matter expert in certified laboratory techniques.
Key Responsibilities:
• Implement and maintain the effectiveness of the quality system in accordance with established procedures
• Perform quality testing on products and review data to determine conformance with specifications
• Execute bioanalytical testing using HPLC, SDS-PAGE, Western Blot, Dot Blot, ELISA, Mass Spectrometry, and microtiter plate methods
• Investigate out of tolerance and out of specification results and provide input for CAPA activities
• Maintain accurate, complete, and compliant documentation and quality records
• Support ticket trending processes and participate in quality investigations
• Manage product and testing inventory in alignment with quality requirements
• Provide quality support for product development and process improvement initiatives
• Monitor testing process performance and implement continuous improvement actions
• Serve as a point of contact for laboratory issues and support scheduling activities as needed
• Ensure adherence to Good Manufacturing Practices and Good Laboratory Practices
• Maintain and update laboratory computer systems and quality applications
• Participate in required training and quality reviews
• Ensure proper storage of samples and documentation
• Actively participate in laboratory safety and environmental health initiatives
Required Qualifications:
• Bachelor’s degree in a scientific or closely related discipline
• Three to four years of experience in a quality role within the healthcare or regulated industry
• Hands-on experience with HPLC, SDS-PAGE, Western Blot, Dot Blot, ELISA, Mass Spectrometry, and microtiter plate methods
• Working knowledge of quality systems and regulated laboratory environments
• Strong written and verbal communication skills
• Ability to work independently in a high-paced laboratory setting
• Basic computer skills and experience working within laboratory information systems
Preferred Qualifications:
• Experience supporting diagnostic product manufacturing and testing
• Knowledge of stability testing, validations, and technical troubleshooting
• Exposure to internal and external audits and quality performance metrics
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.
Pay Range: $25/hr to $30/hr
