Senior Quality Associate

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.
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.

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 escalate risks to Quality Leadership
• Promote a culture of quality, transparency, and accountability
• Perform other duties as assigned

Benefits
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.
Recruiting Agencies, Please Note:
Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.