QC Specialist – Advanced Therapies & Data Integrity

Scorpion Therapeutics; Town of East Greenbush (NY); On-site; USD 85,000 - 125,000; Full time

Job summary

Scorpion Therapeutics in New York State is seeking a QC Specialist to support External Testing in biopharma, focusing on analytical data review for Advanced Therapies. You will verify test results for Release, In-Process, and Stability testing while ensuring cGMP compliance, FDA/EMA/ICH guidelines, and data integrity (ALCOA+).

Responsibilities include evaluating validation documentation, monitoring testing procedures, collaborating with laboratory staff to drive quality improvements, and

Qualifications

• BS/BA in a scientific field with at least 2 years of GMP-related experience.

Responsibilities

• Verifies test results for Release, In-Process, and Stability testing.
• Ensures compliance with cGMP, FDA, EMA, ICH, and data integrity principles (ALCOA+).
• Evaluates validation documentation and monitors testing procedures.
• Collaborates with laboratory staff to drive quality improvements.
• Supports deviation investigations.

Education

BS/BA in a scientific field

Tools

LC

pH

iCIEF

ELISA

SEC

CE-SDS

Job description

Scorpion Therapeutics in New York State is seeking a QC Specialist to support External Testing in biopharma, focusing on analytical data review for Advanced Therapies. You will verify test results for Release, In-Process, and Stability testing while ensuring cGMP compliance, FDA/EMA/ICH guidelines, and data integrity (ALCOA+).

Responsibilities include evaluating validation documentation, monitoring testing procedures, collaborating with laboratory staff to drive quality improvements, and