Quality Assurance Specialist

Position Type: Contract

Duration: 12 Months

About the Role: We are seeking two experienced Senior Quality Specialists to join our team on a contract basis. This role is critical for providing quality assurance and compliance support for our developmental programs. The ideal candidate will have a strong functional knowledge of GMP regulations and will be responsible for ensuring the timely and compliant advancement of clinical products through the lifecycle. You will play a key role in batch disposition, quality system execution, and cross-functional collaboration.

Key Responsibilities: Batch Record Review & Product Disposition: Perform detailed review of executed batch documentation (batch records, COAs, in‑process controls, stability data) from internal and external manufacturers to support the disposition of drug substance, drug product, and finished goods. Quality Systems Management: Support or lead quality system processes, including deviation, out‑of‑specification (OOS), and out‑of‑trend (OOT) investigations, root‑cause analysis and CAPA identification; change control assessment, implementation, and closure. Cross‑Functional Collaboration: Represent Quality on cross‑functional teams, effectively collaborating with colleagues from Pharmaceutical Sciences, CMC Regulatory, Supply Chain, and R&D Quality. Continuous Improvement: Identify and facilitate continuous improvement efforts within the Quality function. Documentation & Agreements: Support the drafting and revision of GMP documents, such as specifications, and Quality Agreements with CMOs and suppliers.

Minimum Qualifications: Bachelor’s degree in a scientific or allied health field (or equivalent).

Operational Experience: Hands‑on QA experience in an analytical or manufacturing setting, with a strong preference for small molecule manufacturing. Experience with biologics, devices, or gene therapy is a plus. Technical Skills Proven proficiency in leading event investigations, Root Cause Analysis (RCA), and CAPA management. Regulatory Knowledge: Expanded conceptual knowledge of cGMPs and their application across the product lifecycle.