Quality Assurance Specialist I
Core
Ensuring compliance with regulatory requirements and cGMP for clinical trial projects and product lifecycle quality assurance.
Role type
Quality Assurance Specialist I
Builds
Clinical trial projects, drug candidates (small molecule and peptide), oral and injectable dosage forms
Domain
Pharmaceutical manufacturing (CDMO), cGMP, regulatory compliance
Deliverable
client delivery
Required skills
GMP environment experience, quality review and release activities, inspection of materials and finished goods, investigation of deviations and complaints, authoring and approving quality documentation, customer service
Preferred skills
JD Edwards (ERP), MS Office (Pivot Tables, VLOOKUP, Excel Formulas, PowerPoint), scientific degree
Technologies
JD Edwards, MS Office
Responsibilities
Perform quality review and release activities for materials, labels, batch records, and certificates of analysis; Conduct inspections of incoming materials, bulk drug products, and packaging operations; Lead and support investigations, deviations, complaints, and change controls; Author, review, update, and approve quality documentation and regulatory records; Train and mentor Quality Specialists; Partner with cross-functional teams to resolve quality issues and present metrics
Seniority
Individual Contributor, 3+ years experience
