Quality specialist III
Core
Drive quality execution across sterile operations including manufacturing, filling, packaging, and inspection for commercial and product development services.
Role type
Quality specialist (pharmaceutical manufacturing)
Builds
Sterile injectable and oral solid dose drug products
Domain
Pharmaceutical industry, sterile manufacturing
Required skills
Quality Assurance, Quality Control, cGMP compliance, aseptic technique, deviation management, batch record review, SOP development, continuous improvement, regulatory inspection support
Preferred skills
Pharmaceutical industry experience, sterile processes, CQA certification, Six Sigma
Technologies
None stated
Responsibilities
Perform daily quality assessments of facility, personnel, and documentation; Assist employees with troubleshooting and aseptic technique guidance; Participate in RAPID event response and provide quality guidance for deviations; Review and approve procedures, training documents, and forms; Perform quality batch record review; Identify and participate in continuous improvement initiatives; Support client quality interactions and regulatory inspections; Develop and maintain BRR SOPs and training materials; Partner with operations to improve documentation accuracy and compliance
Seniority
Mid-level, hands-on IC
