QC Analyst II

Position Summary

This role is responsible for analytical testing and laboratory support in a contract manufacturing facility.

Responsibilities

• Product Testing: In-process and release testing as assigned; techniques include (but not limited to) HPLC, SDS-CGE, ELISA, qPCR, SoloVPE, and compendial testing per USP
• Solution preparation
• Analysis and collation of data to draw conclusions
• Trend analysis using control charting
• Execution of method transfer, method qualification, and/or method validation testing under protocol
• Supports lab investigation and deviation reports
• Supports implementation of Corrective and Preventive Actions
• Tracks department metrics upon request; actively engages in improvement of department metrics
• Ensures state of safety and regulatory audit readiness at all times
• Participates in data review activities, as needed
• Ensures Trainer qualification status to expand team matrix
• Laboratory support

Minimum Requirements

• QC Analyst I requires Bachelor's degree in chemistry, biochemistry or related area (or equivalent training) with 0+ years' experience.
• QC Analyst II requires Bachelor's degree as described and 2+ years' experience or Master's Degree with 0+ years' experience.
• Senior QC Analyst requires Bachelor's degree as described and 4+ years' experience or Master's Degree with 2+ years experience.
• Strong ELISA and other plate-based assays experience preferred
• Experience in QC analysis of proteins, antibodies, peptides, or vaccines a plus, but not required
• Excellent verbal and written communication skills
• Experience working in a cGMP environment preferred

About KBI

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe.