Quality Control Analyst I, Raw Materials

Scorpion Therapeutics; Bedford (MA); On-site; USD 68,000 - 75,000; Full time

Job summary

Scorpion Therapeutics is seeking a QC Analyst I, Raw Materials to perform routine and non-routine testing of raw materials to ensure compliance with internal specifications and regulatory requirements. You will conduct qualitative and quantitative analyses, review data, and support QA and manufacturing teams.

The role requires a Bachelor's degree in Chemistry or Biochemistry and 1–3 years of regulated QC experience, with familiarity in HPLC/GC and cGMP guidelines.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, or related scientific discipline.
• 1-3 years QC laboratory experience (regulated industry preferred).
• Proficiency with analytical techniques and instrumentation.
• Strong understanding of cGMP and GLP/regulatory guidelines.
• Excellent documentation/organizational skills; ability to work independently and in a team.
• Strong problem-solving/critical thinking.

Responsibilities

• Perform qualitative and quantitative testing of raw materials using HPLC, GC, FTIR, UV-Vis, titration, and wet chemistry.
• Review and interpret analytical data; ensure compliance with cGMP, USP, EP, JP, and other applicable standards.
• Support aliquoting, shipment, and coordination of outsourced testing at contract laboratories.
• Assist with QC incoming inspections and AQL activities for raw materials and finished products.
• Assist in preparation/review of SOPs, test protocols, test reports, test methods, and specifications.
• Perform method transfer, validation, and verification per ICH Q2 and cGMP guidelines.
• Investigate and document out-of-specification (OOS) results and deviations.
• Support raw material qualification and requalification.
• Collaborate with QA, procurement, warehouse, and manufacturing to resolve material-related issues.
• Participate in internal and external audits/inspections; ensure lab safety and environmental/regulatory compliance.

Skills

Analytical thinking

Documentation

Regulatory compliance

Team collaboration

Education

Bachelor's degree in Chemistry/Biochemistry

Tools

HPLC

GC

FTIR

UV-Vis

Titration

Wet chemistry

Job description

Position Summary

Quality Control (QC) Analyst I, Raw Materials is responsible for routine and non-routine testing of raw materials to ensure compliance with internal specifications, regulatory requirements, and industry standards. Performs analytical testing, documentation, and cross-functional collaboration to support manufacturing and supply chain operations.

Key Responsibilities

• Perform qualitative and quantitative testing of raw materials using HPLC, GC, FTIR, UV-Vis, titration, and wet chemistry.
• Review and interpret analytical data; ensure compliance with cGMP, USP, EP, JP, and other applicable standards.
• Support aliquoting, shipment, and coordination of outsourced testing at contract laboratories.
• Assist with QC incoming inspections and AQL activities for raw materials and finished products.
• Assist in preparation/review of SOPs, test protocols, test reports, test methods, and specifications.
• Perform method transfer, validation, and verification per ICH Q2 and cGMP guidelines.
• Investigate and document out-of-specification (OOS) results and deviations.
• Support raw material qualification and requalification.
• Collaborate with QA, procurement, warehouse, and manufacturing to resolve material-related issues.
• Participate in internal and external audits/inspections; ensure lab safety and environmental/regulatory compliance.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, or related scientific discipline.
• 1-3 years QC laboratory experience (regulated industry preferred).
• Proficiency with analytical techniques and instrumentation.
• Strong understanding of cGMP and GLP/regulatory guidelines.
• Excellent documentation/organizational skills; ability to work independently and in a team.
• Strong problem-solving/critical thinking.

Preferred Qualifications

• Experience with LIMS.
• Familiarity with compendial testing (USP, EP, JP).
• Knowledge of raw material lifecycle management.

Work Environment

Laboratory setting with chemicals and analytical instruments; occasional lifting up to 25 lbs; use of PPE as required.

Salary Range

$68,000-$75,000 USD