Senior Analyst, Quality Control (Raw Materials)

Role: Senior QC Analyst specializing in raw material testing within a GMP-regulated pharmaceutical setting, primarily for ophthalmic product development using proprietary bioresorbable hydrogel technology. Responsibilities: perform and review complex analytical tests (HPLC, GC, XRPD, Karl Fischer), lead investigations (OOS, OOT, deviations), author SOPs and validate methods, coordinate external testing, support raw material qualification, and mentor junior staff. Collaborates with QA, Manufacturing, Supply Chain, and external labs; participates in audits. Qualifications: Bachelor’s in Chemistry, Biochemistry, or related; 5+ years in GMP QC labs with expertise in analytical instrumentation; familiarity with pharmacopeial standards (USP, EP, JP); experience with LIMS and validation activities. Preferred: experience with regulatory submissions, ICH/FDA guidelines, clean lab operations, and continuous improvement initiatives. Work Environment: laboratory setting with chemical exposure, PPE use required, occasional lifting up to 25 lbs. High-Value Details: focus on raw material qualification, analytical method validation, and GMP compliance; no specific therapeutic area beyond ophthalmic drug delivery. Location and travel specifics are not provided.