Sr. Associate Scientist / Scientist, QC Operations

Liquidia•,

About The Position

The Sr. Associate Scientist / Scientist, QC Operations will serve as the central coordination point for QC testing activities at Liquidia, supporting both internal and external manufacturing operations. This individual will be responsible for tracking and communicating the status of all in-process, release, and stability samples across internal and contract laboratories, issuing Certificates of Analysis (CoAs), reviewing incoming CoAs from contract testing organizations, and ensuring that testing timelines and documentation requirements are met to support batch disposition and regulatory commitments. As Liquidia's batch volumes continue to grow across both internal and external manufacturing, this role will be critical to maintaining visibility, organization, and timely communication across the QC function and its cross-functional partners. The ideal candidate will be highly organized, detail-oriented, and comfortable managing multiple priorities in a fast-paced GMP environment. This is a non-bench role focused on QC operations coordination, testing logistics, and documentation support.

Requirements

Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline required.
Sr. Associate Scientist: 2–5 years of relevant experience in a pharmaceutical or biotechnology QC environment with a B.S., or 1–3 years with an M.S.
Scientist: 5–8 years of relevant experience in a pharmaceutical or biotechnology QC environment with a B.S., or 3–6 years with an M.S.
Working knowledge of cGMP requirements and their application to QC laboratory operations and documentation.
Experience with pharmaceutical testing documentation, including familiarity with Certificates of Analysis, analytical data review, and batch record support.
Strong organizational skills with the ability to manage multiple priorities, track numerous active items simultaneously, and meet deadlines in a fast-paced environment.
Proficiency with Microsoft Office tools (Excel, Word, Outlook, Project) and the ability to build and maintain tracking tools, dashboards, and status reports.
Strong written and verbal communication skills, with the ability to provide clear, concise status updates to cross-functional stakeholders at all levels.
Attention to detail and a commitment to accuracy in documentation, data review, and record-keeping.

Nice To Haves

Experience developing and maintaining tracking systems, dashboards, or operational tools to manage sample flow and testing status across multiple laboratories or sites.
Experience working in or supporting a QC function within a growing or start-up pharmaceutical or biotechnology organization.
Familiarity with stability testing programs, reference standard management, or sample storage and inventory practices.
Experience supporting regulatory inspections or internal audits from a QC documentation or operations perspective.

Responsibilities

Serve as the primary point of contact for tracking the status of QC test samples across internal and contract laboratories, providing timely updates to QC leadership, Quality Assurance, Manufacturing, and Supply Chain stakeholders.
Coordinate the submission of samples to contract testing laboratories, including preparation of sample shipments, chain of custody documentation, and communication of testing requirements and timelines.
Track outsourced testing timelines and proactively follow up with contract laboratories to ensure on-time delivery of results and resolution of any testing delays or issues.
Generate, compile, and issue Certificates of Analysis (CoAs) for internally manufactured and externally manufactured products in support of batch disposition and product release.
Review incoming CoAs and analytical data packages from contract testing laboratories for completeness, accuracy, and compliance with specifications and Liquidia requirements.
Develop and maintain sample and documentation tracking tools, dashboards, and status reports to provide real-time visibility into testing progress, turnaround times, pending activities, and any disposition blockers across all active batches.
Support the batch disposition process by ensuring all required testing documentation, CoAs, and supporting records are complete, organized, and readily available for QA review.
Assist in maintaining and improving QC operations workflows, templates, and tracking systems to support the organization's growing batch volumes and increasing operational complexity.
Support contract laboratory relationship management activities, including scheduling of routine status calls, tracking of open action items, and escalation of issues to QC/QA leadership as needed.
Ensure all QC operations coordination activities are performed in compliance with cGMP requirements, data integrity expectations, and Liquidia internal procedures.
Author, review, and maintain SOPs, work instructions, and templates related to QC sample management, CoA issuance, and outsourced testing coordination.
Support regulatory inspection readiness by ensuring QC testing records, CoAs, and outsourced testing documentation are organized, complete, and audit-ready.
Collaborate cross-functionally with Quality Assurance, Manufacturing, Process Engineering, Regulatory Affairs, and Supply Chain to ensure alignment on testing priorities, timelines, and documentation requirements.
Perform other duties as assigned.