Senior Quality Associate

Clutch Canada; United States; On-site; USD 70,000 - 110,000; Full time

Job summary

Liquidia is seeking 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 properly controlled and issued, contributing to regulatory compliance and inspection readiness.

Ideal candidates have a Bachelor’s in Life Sciences, 2+ years QA experience in a regulated environment, and familiarity with GMP principles and electronic documentation

Qualifications

• Bachelor’s degree in Life Sciences or related field; equivalent work experience may be considered.
• Minimum 2+ years of quality assurance experience in a regulated industry.
• Knowledge of deviation management, CAPA, change control, and document management.
• Experience with FDA inspections preferred; experience with electronic platforms preferred.

Responsibilities

• Maintain robust document management practices, ensuring controlled documents are accurate and current.
• Review and approve deviations, CAPAs, and change controls with root-cause analysis.
• Support day-to-day manufacturing and QC operations by issuing logbooks, forms, and batch records.
• Develop and revise SOPs, work instructions, and templates for quality systems.
• Support Management Review by compiling metrics and reporting quality trends.
• Provide training and guidance on quality systems and best practices.
• Identify quality risks, compliance gaps, and drive continuous improvement initiatives.
• Support inspection readiness activities and elevate risks to Quality Leadership.

Skills

Quality principles

GMP knowledge

EDMS experience

MS Office

Attention to detail

Communication skills

Team collaboration

Education

Bachelor’s degree in Life Sciences or related field

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.

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.

• 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