QC Scientist II
QC Scientists II are experienced analysts who lead complex testing, method development, and troubleshooting within a GMP-regulated Quality Control lab. They often serve as technical mentors to junior staff and support cross-functional investigations.
Key responsibilities:
Executing and overseeing high-complexity tests – Including HPLC, GC, ELISA, endotoxin, and potency assays.
Writing and reviewing protocols and SOPs – Contributing to a compliant and continuously improving quality system.
Leading method validation and transfers – Working with internal teams or contract labs to implement robust analytical methods.
Participating in audits and inspections – Providing scientific justification and data integrity during regulatory or client audits.
Supporting deviations and CAPAs – Assisting in investigations and corrective actions linked to QC results.
This role typically requires several years of QC lab experience and strong documentation and regulatory knowledge.