Research Associate II, Quality Control

Scorpion Therapeutics; Bedford (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Scorpion Therapeutics is seeking a Research Associate II to execute routine Quality Control testing and support CAPAs, investigations, and deviations in a GMP environment.

The role covers development and validation of analytical methods, data review, and lab upkeep within the Analytical Development group, with a mix of office and laboratory work in Bedford, MA.

Qualifications

• Bachelor’s degree in Chemistry or related field.
• 2+ years of experience in a GMP Quality Control environment.
• Prior experience with HPLC and UPLC.

Responsibilities

• Execute QC analytical testing using HPLC, UPLC, GC, KF, dissolution, and other instrumentation.
• Author technical reports as required.
• Ensure instrument calibration and qualification are up to date.
• Troubleshoot instrumentation issues and coordinate vendor repairs.
• Coordinate with Supervisor on scheduling testing for reagents and product samples.
• Participate in data review and method development/validation.
• Coordinate external outsourcing of testing.
• Support CAPAs, change controls, investigations, and deviations; ensure timely closure with Quality Assurance.
• Follow Good Documentation Practices (GDP) and maintain contemporaneous records/logbooks.
• Adhere to cGMPs at all times.

Skills

HPLC/UPLC

GMP

Quality control

Analytical testing

GDP / GDPs

Documentation

Communication

Education

Bachelor’s degree in Chemistry or related field

Tools

None

Job description

Position Summary

As a Research Associate II, execute routine Quality Control (QC) testing activities as assigned. Support CAPAs, change controls, investigations, and deviations; participate in development and validation of analytical methods for the Analytical Development group. Assist with testing, project support, data review, ordering laboratory supplies, and laboratory upkeep.

Principal Duties and Responsibilities

• Support QC analytical chemistry testing using HPLC, UPLC, GC, KF, dissolution, and other instrumentation.


• Author technical reports as required.


• Ensure instrument calibration and qualification are up to date.


• Troubleshoot instrumentation issues and coordinate vendor repairs.


• Coordinate with Supervisor on scheduling testing for reagents and product samples.


• Participate in data review.


• Participate in method development and validation.


• Coordinate external outsourcing of testing.


• Support CAPAs, change controls, investigations, and deviations; ensure timely closure with Quality Assurance.


• Follow Good Documentation Practices (GDP) and maintain contemporaneous records/logbooks/forms.


• Adhere to cGMPs at all times.

Requirements

• Bachelor’s degree in Chemistry or related field.


• 2+ years of experience in a GMP Quality Control environment.


• Prior experience with HPLC and UPLC.

Preferred

• Knowledge of CFR 210, 211, USP, and FDA/ICH guidance.


• Experience with USP App IV dissolution apparatus.

Skills/Knowledge

• Knowledge of safe laboratory practices.


• Strong verbal and written communication.

Working Conditions

Mix of office and laboratory environments; must be able to work in chemical laboratory environments.