Quality Control Supervisor, cGMP Lab Lead

Scorpion Therapeutics; Chapel Hill (NC); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Medical/dental/vision/prescription

401k/ESPP

Paid time off

Paid parental leave

Disability benefits

Job summary

Scorpion Therapeutics is seeking a Supervisor of Quality Control to lead QC operations in alignment with cGMP standards. The role includes overseeing testing of raw materials, in-process samples, drug substances, and drug products, plus coordination of method transfers and equipment qualification.

You will supervise hands-on QC testing, manage contract labs, review data packages, and drive investigations and CAPA while mentoring Analytical Chemists and ensuring compliance with regulatory

Qualifications

• Bachelor’s degree in chemistry or a scientific discipline.
• 5+ years GMP pharmaceutical lab experience.
• cGMP/QC lab knowledge; wet chemistry and cell-based assay experience; LIMS familiarity.
• Strong written/verbal communication; detail-oriented and able to work independently.
• Experience managing contract labs and reviewing external data packages.
• Prior lead experience.

Responsibilities

• Supervise QC operations for testing of materials and products per cGMP standards.
• Coordinate and prioritize day-to-day laboratory activities (routine/ad-hoc testing, method transfers, equipment qualification).
• Perform hands-on QC testing using wet chemistry and cell-based assays.
• Coordinate with external contract laboratories (sample shipment, method transfers, data review).
• Provide oversight of OOT/OOS/deviation investigations and CAPA; elevate complex events to QC Management.
• Review/approve analytical chemistry data packages for conformance to specifications and cGMP.
• Draft/review protocols, summary reports, and SOPs; support testing as needed.
• Support IQ/OQ/PQ of new/transferred laboratory equipment; coordinate vendor work.
• Implement regulatory/compendial changes relevant to QC Analytical Chemistry.
• Provide training and on-the-job oversight for Analytical Chemists/Analysts.
• Troubleshoot instrument and LIMS issues.

Skills

GMP experience

Lead experience

Strong communication

Independent worker

Education

Bachelor’s in chemistry

Master’s degree (preferred)

Tools

LIMS

cGMP documentation

Job description

Scorpion Therapeutics is seeking a Supervisor of Quality Control to lead QC operations in alignment with cGMP standards. The role includes overseeing testing of raw materials, in-process samples, drug substances, and drug products, plus coordination of method transfers and equipment qualification.

You will supervise hands-on QC testing, manage contract labs, review data packages, and drive investigations and CAPA while mentoring Analytical Chemists and ensuring compliance with regulatory