QC Analyst II

KBI Biopharma•Durham, NC

3d•Onsite

About The Position

This role is responsible for analytical testing and laboratory support in a contract manufacturing facility. At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.

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.
Strong ELISA and other plate-based assays experience preferred
Excellent verbal and written communication skills
Experience working in a cGMP environment preferred

Nice To Haves

Experience in QC analysis of proteins, antibodies, peptides, or vaccines a plus, but not required

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