Senior QC Analyst (2nd Shift) - In-Process

NCBiotech; Durham (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

KBI Biopharma, located in Durham, NC, seeks a Senior QC Analyst (2nd Shift) to perform analytical testing on in-process, characterization, release, and stability samples using HPLC, ELISA, qPCR and related techniques.

The role emphasizes data integrity and GxP compliance, with responsibilities including method transfer/qualification/validation, data entry into LIMS, investigations, SOP revisions, and on-site collaboration for continuous improvement.

Qualifications

• Relevant degree and 4–8 years’ biopharmaceutical industry experience, preferably in protein analytics.

Responsibilities

• In-process, characterization, stability, and/or release testing using HPLC, ELISA, qPCR and related techniques.
• Execute method transfer, qualification, and validation testing under protocol.
• Prepare solutions and process samples per GxP standards.
• Analyze data independently and enter into control charts/LIMS as applicable.
• Support investigations, deviations, CAPAs, and SOP revisions.
• Assist with STAT testing coordination and on-site lab operations.
• Maintain laboratory safety and audit readiness; ensure cGMP compliance.

Skills

HPLC

ELISA

qPCR

Capillary electrophoresis

LIMS

GxP

Data analysis

Troubleshooting

Education

Bachelor's degree

Tools

LIMS

Job description

This role contains the following responsibilities covering 2nd shift hours (2:00 pm through 10:30 pm), Monday through Friday:

The Senior QC Analyst (2nd Shift) will be trained to execute analytical test methods and their corresponding analytical techniques. The core function is composed of completing QC testing for in-process, characterization, release, or stability samples. Additionally, when need arises, Senior QC Analyst will assist with troubleshooting and support In-process Support Associates with STAT samples during 2nd shift.

Responsibilities include:

• 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, if applicable
• Supports lab investigation and deviation reports
• Supports implementation of Corrective and Preventive Actions
• Revises SOPs and technical documents
• 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
• Participates in data review activities
• Duties may include support in STAT testing coordination
• 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:

Relevant degree and 4-8 years’ biopharmaceutical industry experience, preferably in protein analytics

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.