Quality Engineer

BioIVT; United States; On-site; USD 80,000 - 110,000; Full time

Job summary

BioIVT in the United States seeks a Quality Engineer to promote a culture of quality across the organization. You will ensure products, processes, and systems meet regulatory standards and customer expectations.

The role focuses on developing and maintaining QMS, SOPs, training, and documentation, while guiding cross-functional teams in GDP, GLP, cGMP, and FDA compliance. A strong communicator with attention to detail will help prepare for inspections and drive continuous improvement within

Qualifications

• Knowledge of GDP/GLP/cGMP and FDA regulations.
• Experience creating and maintaining SOPs and training materials.
• Familiarity with internal and external audits.
• Strong documentation and record-keeping skills.

Responsibilities

• Develop, implement, and maintain GxP QMS for BioIVT sites.
• Establish quality programs to monitor product quality and compliance.
• Prepare for internal, customer, and regulatory inspections.
• Support audit programs and produce audit reports.

Skills

GxP Quality Management

Regulatory Compliance

Documentation & SOPs

Audit & Inspection

Job description

BioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens, including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research, aiming to improve patient outcomes by coupling comprehensive clinical data with donor samples. As the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science

Position Summary

The Quality Engineer plays a critical role in promoting, supporting, and fostering a culture of quality throughout the organization. This position is responsible for ensuring that products, processes, and quality systems meet applicable regulatory requirements, industry standards, and customer expectations. The Quality Engineer supports the development, implementation, and maintenance of quality management systems (QMS) and compliance programs while driving continuous improvement initiatives across multiple business functions.

A significant portion of this role involves the creation, review, approval, and maintenance of Standard Operating Procedures (SOPs), training materials, and quality documentation. The Quality Engineer will also facilitate training programs to ensure employees understand and comply with applicable regulations, internal policies, and quality system requirements in a practical, fit-for-purpose manner that supports business objectives.

Location Requirement:

Candidates must reside within the Eastern Time Zone (EST/EDT). While we consider applications from most states, we are unable to hire in AK, HI, NM, ND, SD, RI, or VT.

Regulatory And Compliance Requirements

• Good Documentation Practices (GDP)
• Good Laboratory Practices (GLP)
• Current Good Manufacturing Practices (cGMP)
• FDA regulations and guidance
• Standard Operating Procedures (SOPs)
• State Departments of Health requirements
• Clinical Laboratory Improvement Amendments (CLIA)
• College of American Pathologists (CAP) standards
• United States Pharmacopeia (USP) requirementsGood Clinical Practice (GCP)
• Human Research Protection (HRP) regulations and standards
• Global data privacy regulations
• ISO 9001 standards (2015;13485)
• USDA regulations
• Human Tissue Authority (HTA) licensing requirements, where applicable
• DEA and state-controlled substance regulations, where applicable
• Other applicable federal, state, and international regulations

Essential Duties And Responsibilities

The responsibilities listed below are representative of the role and are not intended to be all-inclusive.

Quality Systems and Compliance

• Develop, implement, and maintain compliant GxP Quality Management Systems (QMS) for assigned BioIVT sites.
• Establish and monitor quality programs to evaluate product quality, process performance, and regulatory compliance.
• Support site readiness for internal, customer, and regulatory inspections.

Audit Management

• Support and participate in internal audit programs through risk-based facility and process audits.
• Prepare audit reports