QA Specialist, Quality Operations - 2nd shift

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 arterial hypertension (PAH). 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 Assurance (QA) Associate is responsible for ensuring GMP operations are performed in compliance with regulatory requirements, internal procedures, and industry best practices. This role provides real-time Quality Assurance oversight of GMP operations, with a focus on batch disposition readiness, deviation management, and sustained inspection readiness.

Schedule: 12-hour 2-2-3 rotating shift (2nd shift with flexibility needed for on-call off-shift)

Job responsibilities

• Provide on-the-floor QA support during manufacturing operations, including GMP guidance, line clearance, room and equipment release, and real-time quality decision-making.
• Review and approve batch production records for accuracy, completeness, and compliance with cGMP requirements and internal procedures.
• Conduct routine QA walkthroughs and internal audits of GMP areas to identify gaps and reinforce quality expectations.
• Review and approve deviations, CAPAs, and change controls, ensuring robust root cause analysis and timely closure.
• Identify quality risks, compliance gaps, and improvement opportunities, and drive continuous improvement initiatives.
• Support inspection readiness activities and serve as a Quality Operations SME during regulatory inspections, including backroom support and direct interaction with investigators.
• Monitor quality trends and appropriately escalate risks to Quality Leadership.
• Promote a culture of quality, transparency, and accountability.
• Perform other duties as assigned.

Job requirements

Education and Experience

• Bachelor's degree in a scientific, engineering, or related discipline.
• Minimum 5 years of experience in Quality Assurance in a cGMP-regulated pharmaceutical, biotechnology, or medical device environment.
• Demonstrated experience with batch record review, deviations, CAPAs, and change control management.
• Experience supporting manufacturing operations in a cross-functional QA role.

Knowledge, Skills and Abilities

• Experience in a real-time, on-the-floor QA support model (e.g., QA-on-the-floor/person-in-plant).
• Experience with electronic quality management systems (e.g., MasterControl, Veeva Vault, TrackWise)
• Experience reviewing and approving deviations, CAPAs, and change controls.

Job benefits

Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off 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.