Quality Control Specialist

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

Role:

QC Specialist supporting External Testing in biopharma, primarily focused on analytical data review for Advanced Therapies. Responsibilities include verifying test results for Release, In-Process, and Stability testing, ensuring compliance with cGMP, FDA, EMA, ICH, and data integrity principles (ALCOA+). The role also involves evaluating validation documentation, monitoring testing procedures, collaborating with laboratory staff for quality improvements, and supporting deviation investigations.

Qualifications:

BS/BA in a scientific field with at least 2 years of GMP-related experience; technical expertise in analytical methods such as LC, pH, iCIEF, ELISA, SEC, and CE-SDS.

Preferred:

experience in biologics, cell/gene therapy, or advanced therapies; familiarity with regulatory guidelines and data integrity standards.

High-Value:

supporting quality assurance in advanced therapies (biologics/cell/gene), cGMP environment, analytical testing, data review, and documentation practices.

Work Setup:

Monday-Friday, 8:0 am–4:30 pm, on‑site; no explicit travel requirements.