QC Analyst II

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.

Position Summary:

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

Position 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
• 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

Minimum Requirements:

• QC Analyst I requires Bachelors degree in chemistry biochemistry or related area (or equivalent training) with 0 years experience. QC Analyst II requires Bachelors degree as described and 2 years experience or Masters Degree with 0 years experience. Senior QC Analyst requires Bachelor degree as described and 4 years experience or Masters 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. For more information visit .

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. Thats why we actively seek individuals from all backgrounds regardless of race color national origin religion gender gender identity sexual orientation age disability or veteran status and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

KBI Biopharma Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore all qualified applicants regardless of race color national origin religion gender gender identity sexual orientation age disability or veteran status are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma Inc. to hire me. If I am hired I understand that either KBI Biopharma Inc. or I can terminate my employment at any time and for any reason with or without cause and without prior notice. I understand that no representative of KBI Biopharma Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma Inc. to contact references provided for employment reference checks. If any information I have provided is untrue or if I have concealed material information I understand that this will constitute cause for the denial of employment or immediate dismissal.