Senior QC Analyst

Position Summary:

These roles are responsible for analytical testing and laboratory support in a contract manufacturing facility.

Position Responsibilities:

• Testing: In-process, characterization, stability, and/or release testing as assigned. Capabilities include (but not limited to) HPLC, ELISA, qPCR, SoloVPE, other spectrophotometric techniques, capillary electrophoretic techniques, and compendial testing per USP with near-zero error and minimal guidance or direction

• Execution of method transfer, method qualification, and/or method validation testing performed under protocol

• Solution preparation

• Organizes and processes samples according to GxP standards

• Independent analysis and collation of data to draw conclusions

• Enter data into control charts and LIMS; perform trend analysis

• Supports lab investigation and deviation reports

• Supports implementation of Corrective and Preventive Actions

• Authors or revises SOPs, protocols, or technical reports

• Supports team to troubleshoot testing or project challenges with comfort in presenting and communicating data

• Tracks department metrics upon request; actively engages in improvement of department metrics

• Partakes in continuous improvement projects or leading simple improvement projects

• Ensures state of safety and regulatory audit readiness at all times

• Maintains work to current Good Manufacturing Practices (cGMP)

• Ensures Trainer qualification status to expand team matrix

• Laboratory support - ensures areas are neat, clean, organized, and equipment is functioning

• 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:

• Senior QC Analyst requires Bachelor’ degree as described and 4+ years’ experience or Master’s Degree with 2+ years experience.

• Strong ELISA experienced preferred.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.