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

KBI Biopharma, Inc.; Durham (NC); On-site; USD 63,000 - 86,900; Full time

Job summary

KBI Biopharma, Inc. is hiring a Senior QC Analyst to perform crucial laboratory testing during 2nd shift hours. Candidates must hold a relevant degree and have 4–8 years of experience in the biopharmaceutical industry, particularly in protein analytics. Responsibilities include executing various QC tests and supporting lab investigations while ensuring GMP compliance.

The salary for this position ranges from $63,000 to $86,900, with an emphasis on creating a diverse workplace.

Qualifications

• 4–8 years of experience in the biopharmaceutical industry, preferably in protein analytics.
• Ability to execute analytical test methods and support lab investigations.

Responsibilities

• Conduct QC testing for in-process, characterization, release, or stability samples.
• Participate in method transfer, qualification, and validation testing.
• Maintain labs to Good Manufacturing Practices (cGMP).

Skills

HPLC

ELISA

qPCR

spectrophotometric techniques

capillary electrophoresis

Education

Relevant degree

Job description

Position Summary

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

• 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.

Requirements

• Position is required to be onsite full time with a minimum of 75% of time in the laboratory/facility.
• Relevant degree and 4–8 years’ biopharmaceutical industry experience, preferably in protein analytics.

Compensation

Salary: $63,000–$86,900.

Equal Opportunity Employer

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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.