KBI Biopharma · 2 hours ago
Senior QC Analyst (2nd Shift) – In-Process
Durham, NC
Full-time
Onsite
Mid, Senior Level
$63K/yr - $87K/yr
4+ years expKBI Biopharma is a company focused on biopharmaceutical solutions, and they are seeking a Senior QC Analyst for their 2nd shift operations. The role involves executing analytical test methods, completing QC testing for various samples, and supporting troubleshooting efforts in the lab.
BiopharmaBiotechnologyHealth CareManufacturing
Responsibilities
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
Qualification
Required
Relevant degree and 4-8 years' biopharmaceutical industry experience, preferably in protein analytics
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
Company
KBI Biopharma
KBI Biopharma, Inc. (KBI) is a leading development and contract manufacturing organization serving the biopharmaceutical industry. We help
1001-5000 employees
H1B Sponsorship
KBI Biopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (11)
2023 (18)
2022 (26)
2021 (14)
2020 (21)
Funding
Current Stage
Late StageTotal Funding
$109.47MKey Investors
JSR
2025-10-01Corporate Round· $99.87M
2016-12-08Series Unknown
2009-09-22Series Unknown· $9.6M
Leadership Team
Peter Carbone
Chief Operating Officer
Sigma Mostafa
Chief Scientific Officer
Recent News
Kalaris Therapeutics, Inc.
2025-11-14
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