Sr. Quality Associate, Quality Operations

Liquidia•,

3d•Onsite

About The Position

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.

Requirements

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.
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.

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.