QA Specialist (Oligonucleotides/VLPs)
Core
Ensuring compliance with QA policies, cGMPs, and SOPs for oligonucleotides and virus-like particles (VLPs) by reviewing batch records, managing deviations, and approving investigations.
Role type
Quality Assurance Specialist (Oligonucleotides/VLPs)
Builds
Dispositioning of raw materials and product (VLPs, si-RNA) from Contract Manufacturing Organizations
Domain
Biopharmaceutical manufacturing (Oligonucleotides/VLPs)
Deliverable
client delivery
Required skills
Batch record review, deviation investigation, CAPA management, document control, status labeling, process evaluation
Preferred skills
VLP or si-RNA manufacturing operations knowledge, computerized systems proficiency
Responsibilities
Reviewing and approving batch records from CMOs, representing QA in deviations and change controls, providing QA policy consultation, performing raw material and product disposition activities, reviewing and approving controlled documents, evaluating investigations, performing status labeling, evaluating processes for continuous improvement
Seniority
Mid-level IC (4+ years experience for Specialist level)