Senior Quality Associate

Liquidia Corporation; Morrisville (NC); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits package

401(k) Savings Retirement Plan

Employee stock purchase plan (ESPP)

Job summary

Liquidia Corporation in North Carolina seeks a Senior Quality Associate to support core quality systems, including deviation management, change control, document management, CAPA, issuance, and quality system metrics. This role ensures GMP records are kept accurate and compliant, contributing to inspection readiness and continuous improvement.

The candidate will drive quality systems, provide guidance, and help maintain regulatory posture across manufacturing and QA operations.

Qualifications

• Bachelor’s degree in Life Sciences or related field; equivalent experience considered.
• Minimum 2+ years of QA experience in a regulated industry.
• Experience with deviation management, CAPA, change control, and document management.
• FDA inspection experience preferred.
• Experience with electronic platforms (Veeva, Kneat) preferred.
• Excellent organizational and communication skills.
• Detail-oriented with a commitment to compliance and quality.

Responsibilities

• Maintain robust document management practices with current controlled documents.
• Review and approve deviations, CAPAs, and change controls with root-cause analysis.
• Support day-to-day manufacturing and QC operations with logbooks, forms, batch records, and labels.
• Develop and revise SOPs, work instructions, and templates for quality systems.
• Support Management Review by compiling metrics.
• Provide training and guidance on quality systems and best practices.
• Identify quality risks, gaps, and improvement opportunities; drive improvements.
• Support inspection readiness activities.
• Monitor quality trends and elevate risks to Quality Leadership.
• Promote a culture of quality, transparency, and accountability.
• Perform other duties as assigned.

Skills

Quality systems

Attention to detail

Organizational skills

Communication skills

Microsoft Office

Electronic document management

Education

Bachelor’s degree in Life Sciences

Tools

Veeva

Kneat

Job description

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

Job Summary

The Senior Quality Associate is responsible for supporting core quality systems, including deviation management, change control management, document management, CAPA management, Issuance, and quality system metrics management. This role ensures proper control, archival, and issuance of GMP records. This role ensures compliance with regulatory requirements, internal standards, drives continuous improvement across the organization, and plays a critical part in maintaining the company’s inspection readiness and compliance posture.

Responsibilities

• Maintain robust document management practices, ensuring controlled documents are accurate, current, and complaint
• Review and approve deviations, CAPAs, and change controls ensuring robust root cause analysis and timely closure
• Support day to day manufacturing and QC operations by issuing logbooks, forms, batch records, and labels.
• Develop and revise SOPs, work instructions, and templates related to quality systems
• Support Management Review including compiling appropriate metrics
• Provide training and guidance to staff on quality systems and best practices
• Identify quality risks, compliance gaps, improvement opportunities, and drive continuous improvement initiatives
• Support inspection readiness activities
• Monitor quality trends and appropriately elevate risks to Quality Leadership
• Promote a culture of quality, transparency, and accountability
• Perform other duties as assigned

Requirements

Education and Experience

• Bachelor’s degree in Life Sciences, or a related field preferred; equivalent work experience may be considered.
• Minimum 2+ years of experience in quality assurance within a regulated industry.
• Knowledge of quality systems: deviation management, corrective and preventative actions, change control, and document management.
• Experience with routine FDA regulatory inspections preferred.
• Experience with electronic platforms (e.g., Veeva, Kneat) preferred.
• Excellent organizational and communication skills.
• Detail-oriented with a commitment to compliance and quality

Knowledge, Skills, and Abilities

• Knowledge of Quality principles, concepts, systems, industry practices, and standards in relation to document management, training, change control, deviations and corrective/preventive actions.
• Understanding of Good Manufacturing Practices (GMP) and applicable regulatory expectations for documentation in the industry.
• Strong proficiency with electronic document management systems and Microsoft Office Suite (Word, Excel).
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities.
• Effective verbal and written communication skills; ability to interface across the organization.
• Proven ability to work both independently and collaboratively in a team environment.

Liquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, and more!

Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.