Quality Assurance Specialist (Contract Position)

Job Description

Job Description

About Alveo

At Alveo Technologies, we are reshaping diagnostics for a healthier and more sustainable future. We are the first company to make molecular detection and diagnostics universally accessible – on the farm and in the field, clinic or manufacturing plant – helping to prevent or significantly limit the destructive impact of viruses, fungi, bacteria and other pathogens. By decentralizing molecular diagnostics across a broad range of industries, we are enabling rapid detection and decision making, timely action and better outcomes at the Point of Need™. Our portable, multiplex-capable diagnostic platform, Alveo Sense™, employs a patented method of direct electrical sensing of nucleic acid amplification to provide quick, affordable and accurate results. Through early pathogen detection, we help manage global animal and human health, food security, and supply chain resiliency by providing actionable insights at light speed. Know Sooner, Act Faster™ with Alveo.

As a Quality Assurance Specialist, you will support the implementation and maintenance of the organization’s Quality Management System (QMS) to ensure products and processes meet established quality, regulatory, and performance requirements. This role is responsible for supporting Quality Assurance activities across document control, training compliance, equipment calibration tracking, batch record review, and lot release activities within a regulated laboratory and manufacturing environment. 

Key Responsibilities 

1. Document Review and Control: 

• Review controlled quality documents for formatting, completeness, accuracy, and compliance with company procedures prior to approval routing. 

• Assist with processing document changes, document routing, version updates, obsolescence, and archival activities within the electronic Quality Management System (eQMS). 

• Maintain controlled records and ensure documents are properly filed, organized, and retrievable in accordance with document control procedures. 

• Review customer facing materials, labeling, and product documentation to ensure approved content and proper document control prior to release. 

1. Training and Support: 

• Assign required training within the electronic Quality Management System (eQMS) based on document revisions, new procedures, onboarding activities, and training plans. 

• Monitor training completion status and follow up with employees and managers regarding overdue or incomplete training assignments. 

• Maintain accurate and current training records in accordance with company procedures and Quality Management System requirements.  

• Escalate overdue training, missing records, or training compliance issues to QA management, as appropriate. 

1. Equipment Calibration and Maintenance: 

• Maintain calibration and preventive maintenance schedules for laboratory and manufacturing equipment. 

• Coordinate calibration and maintenance activities with internal personnel and external service providers. 

• Track completion of calibration and maintenance activities and ensure records are uploaded and maintained in the appropriate systems. 

• Review calibration certificates and maintenance records for completeness and accuracy prior to filing. 

• Notify management of overdue calibrations, maintenance activities, or equipment status concerns. 

• Assist with equipment labeling and status tracking to ensure calibrated equipment is properly identified. 

1. Batch Record Review / Lot Release: 

• Perform review of batch records, test records, and supporting documentation for completeness, legibility, and adherence to approved procedures. 

• Verify that required signatures, dates, calculations, and supporting documentation are present and complete prior to QA approval or escalation. 

• Assist with review of production and laboratory records to support lot release activities. 

• Identify documentation errors, discrepancies, or missing information and communicate findings to the appropriate department for correction. 

• Perform product disposition and lot release activities in accordance with approved procedures and quality requirements. 

• Maintain organized and traceable batch record and release documentation in accordance with record retention requirements. 

Education and Experience: 

• Bachelor’s degree in Biological Sciences, Biomedical Engineering, Chemistry, Microbiology, or related scientific field, or equivalent combination of education and industry experience. 

• Minimum of 3 years of experience working within a regulated laboratory, manufacturing, or quality environment. 

• Experience working within regulated industries, preferably medical device, in vitro diagnostics, biotechnology, pharmaceutical, or related industries, with exposure to Quality Management Systems (QMS). 

• Experience with electronic Quality Management Systems (eQMS) or electronic document management systems (eDMS) required. 

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.