- Location
- Bend, Oregon
- Workplace
- Onsite
- Type
- Full-time
- Department
- Quality
- Seniority
- Entry
- Source
- Lever
Description
Serán BioScience is searching for an experienced Quality Assurance Associate to aid in regulatory compliance for the manufacturing of oral solid dosage drug products. The primary responsibilities of this role will be to support the daily activities of Serán’s Quality Assurance department by ensuring GMP regulations and internal SOPs are followed throughout the clinical manufacturing process. Essential task include reviewing and approving production records, analytical data, and internal QA documentation. Additional responsibilities include conducting risk analyses and investigations and participating in audits and inspections. Quality experience in a GMP Pharmaceutical Manufacturing setting is a requirement for this position with the ability for the title and compensation to commensurate with experience.
This role will support the alternative manufacturing schedule from Monday - Thursday, beginning at 2:00 pm and ending at 1:00 am. Experience specific to Serán's manufacturing capabilities and confidence to make independent decisions in alignment with Company policies and risk mitigation philosophies will be critical to this role.
Skills
GMPFDACompliance
