
Serán BioScience
Posted 22 days ago
Quality Assurance Associate II/III
Bend, OregonOn-siteFull-time
AI Summary
Quality Assurance Associate ensures GMP/compliance in manufacturing, conducts audits, supports supplier quality, and drives QMS improvements for oral solid dosage production.
About this role
Serán BioScience is searching for an experienced Quality Assurance Associate to aid in regulatory compliance for the manufacturing of oral solid dosage drug products. As a Quality Assurance Associate, you will be responsible for performing the day-to-day tasks of the QA Department supporting a GMP facility manufacturing and testing pharmaceutical products. Tasks include auditing and audit support, supplier quality management, and continuous improvement. Additional responsibilities include Quality Management System, risk analyses, change management and investigations/CAPA. Preference will be given to candidates with Quality Assurance experience in the pharmaceutical industry, while those with Quality oversight experience are encouraged to apply.
Duties and Responsibilities
Required Skills and Abilities
Education and Experience
Physical Requirements
Skills
AuditingCAPAChange ControlDocumentationFDA Regulations 21CFR 210-211GMPInternal And External AuditsQA/QC In Pharmaceutical ManufacturingQuality RecordsRisk AssessmentSOP AuthorshipSOPsSupplier Quality ManagementVeeva