Quality Engineer

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 applicants from most states, we are unable to hire in AK, HI, NM, ND, SD, RI, or VT.

Regulatory and Compliance Requirements

The Quality Engineer is responsible for ensuring compliance with applicable Environmental Health and Safety (EHS) policies and regulatory requirements, including but not limited to:

- 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, communicate findings to management, and ensure appropriate documentation and follow-up activities.

- Coordinate corrective actions and verify effective closure of audit observations.

- Support supplier and vendor qualification audits, including routine and for-cause assessments.

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