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 RequirementsThe 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 ResponsibilitiesThe 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.
Quality Investigations and CAPA- 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).
Validation and Product Release Support- 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.
Quality Metrics and Continuous Improvement- 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.
Cross-Functional Collaboration- 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.
Additional Responsibilities- Perform other duties as assigned that are consistent with the employee's training, experience, and qualifications.
Travel RequirementsThis is a remote position; however, travel is required to support site operations, audits, inspections, training, and other business needs.
- Up to 40% travel may be required annually.
QualificationsEducation and Experience- 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.
- Equivalent combinations of education and relevant experience may be considered.
Knowledge, Skills, and Abilities- 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.
- Experience with electronic Quality Management Systems (eQMS); MasterControl experience is preferred.
Physical DemandsReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
While performing the duties of this role, the employee may be required to:
- Sit, stand, walk, bend, stoop, kneel, crouch, and reach.
- Use hands and fingers to operate computer equipment and laboratory tools.
- Communicate effectively through speaking, hearing, and writing.
- Maintain visual acuity, including close vision, color vision, depth perception, and focus adjustment.
- Frequently lift and/or move objects weighing up to 10 pounds and occasionally lift and/or move objects weighing up to 30 pounds.
Work EnvironmentThis position is classified as a combination of Administrative and Laboratory Support.
The employee will regularly work in a professional office environment and may periodically work in laboratory, manufacturing, warehouse, or other controlled environments.
Exposure may include:
- Personal protective equipment (PPE) requirements
- Biological materials and biohazards
- Hazardous chemicals and controlled substances
- Airborne particles and laboratory fumes
- Flammable materials
- Radiation sources (where applicable)
- Mechanical equipment and moving parts
- Electrical equipment
Noise levels are generally moderate but may occasionally require hearing protection. Work may be performed in a variety of indoor and outdoor environments and environmental conditions.
DisclaimerThis job description is intended to describe the general nature and level of work performed by employees assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, or qualifications. Responsibilities may change based on business needs. Employees may be required to perform other job-related duties as assigned and must comply with all applicable company policies and federal, state, and local regulations.
Employment is at-will unless otherwise governed by applicable law or a written employment agreement.
We offer a comprehensive benefit package for eligible team members, including medical, dental, vision, short-term/long-term disability, life insurance, hospital indemnity and accident insurance. We also provide a generous retirement plan with a company match. Eligible employees enjoy competitive time-off policies and a collaborative environment that promotes growth from within. Enjoy company-sponsored events for the entire team!
