Quality Engineer

BioIVT•Remote US, US,

16d•Remote

About The Position

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

Requirements

Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biotechnology, Microbiology, or related field) required.
Minimum of 15 years of relevant experience in Quality Assurance, Quality Systems, Operations, Manufacturing, or related functions within the pharmaceutical, biopharmaceutical, biotechnology, medical device, or regulated life sciences industries.
Strong working knowledge of cGMP, GLP, GDP, and other applicable quality and regulatory compliance requirements.
Comprehensive understanding of Quality Management Systems and GxP regulations.
Strong knowledge of biological products, laboratory operations, and cell culture best practices.
Understanding of analytical test methods, product specifications, and data interpretation.
Proven experience conducting audits, investigations, risk assessments, and CAPA management.
Excellent analytical, problem-solving, and decision-making abilities.
Strong organizational skills with exceptional attention to detail and documentation accuracy.
Excellent written and verbal communication skills, including technical writing and report preparation.
Demonstrated ability to work effectively in cross-functional teams and influence stakeholders at multiple organizational levels.
Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and database systems.

Nice To Haves

Experience with electronic Quality Management Systems (eQMS); MasterControl experience is preferred.
Equivalent combinations of education and relevant experience may be considered.

Responsibilities

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.
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.
Lead or support root cause investigations related to deviations, nonconformances, complaints, and quality events.
Collaborate cross-functionally to resolve quality issues and drive systemic improvements.
Facilitate the development, implementation, and effectiveness verification of Corrective and Preventive Actions (CAPA).
Coordinate, review, and approve validation protocols, reports, and supporting documentation.
Provide quality oversight for qualification and validation activities.
Support product release decisions by evaluating specifications, quality data, and risk assessments.
Collect, compile, analyze, and trend quality and operational data to identify improvement opportunities.
Monitor key quality performance indicators and provide recommendations to enhance product quality and process consistency.
Prepare and present quality metrics and performance reports for Quality Assurance and Regulatory Affairs leadership.
Participate in continuous improvement initiatives focused on quality system effectiveness and operational excellence.
Partner with Production, Operations, Laboratory, Regulatory Affairs, and other functional teams to address quality concerns and improve processes.
Participate in routine cross-functional meetings to review quality performance and resolve issues.
Provide guidance and support on quality requirements and best practices throughout the organization.
Perform other duties as assigned that are consistent with the employee's training, experience, and qualifications.