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

Location: Onsite full time at Hamlin Road in Durham, North Carolina, USA; minimum 75% of time in the laboratory or facility. Second shift is 2:00 pm–10:30 pm, Monday through Friday.

Salary: $63,000–$86,900 per year

Company

hirify.global is a biopharmaceutical organization operating a regulated laboratory and manufacturing environment.

What you will do

• Execute in-process, characterization, release, stability, and STAT sample testing.
• Perform analytical testing using HPLC, ELISA, qPCR, SoloVPE, spectrophotometric, capillary electrophoretic, and USP compendial techniques.
• Conduct method transfer, qualification, and validation testing under approved protocols.
• Prepare solutions, organize samples according to GxP standards, and enter data into control charts and LIMS.
• Analyze and review data, support investigations and deviations, and implement corrective and preventive actions.
• Support troubleshooting, SOP and technical document revisions, continuous improvement, training qualification, and laboratory readiness.

Requirements

• Relevant degree.
• 4–8 years of biopharmaceutical industry experience, preferably in protein analytics.
• Ability to perform QC analyses independently with minimal guidance and near-zero error.
• Experience working under cGMP and GxP standards and supporting regulatory audit readiness.
• Availability for onsite second-shift work in Durham, North Carolina, with at least 75% of time spent in the laboratory or facility.

Culture & Benefits

• Full-time employment in a safety-focused laboratory environment.
• Work is organized around current Good Manufacturing Practices and regulatory audit readiness.
• Participation in continuous improvement projects and department metric tracking.
• Workplace vaccination status must be submitted for employees entering a KBI site in the United States; FDA-approved or authorized COVID-19 vaccination proof is required for vaccinated employees.