QC Analyst II

KBI Biopharma•Durham, NC

1d•Onsite

About The Position

This role is responsible for analytical testing and laboratory support in a contract manufacturing facility. At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.

Requirements

Bachelor’s degree in chemistry, biochemistry or related area (or equivalent training) with 2+ years’ experience, or Master’s Degree with 0+ years’ experience.
Excellent verbal and written communication skills

Nice To Haves

Strong ELISA and other plate-based assays experience preferred
Experience in QC analysis of proteins, antibodies, peptides, or vaccines a plus, but not required
Experience working in a cGMP environment preferred

Responsibilities

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
It is the expectation that this position is required to be onsite full time with a minimum of 75% of time in the laboratory/facility