Quality Control Analyst II

Scorpion Therapeutics; Cincinnati (OH); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

401(k) match

Paid Time Off

Life/disability insurance

Job summary

Scorpion Therapeutics in Cincinnati leads advanced pharmaceutical research, offering a role focusing on routine and non-routine chemical testing in a GMP environment. The analyst will perform qualitative and quantitative analyses, manage data via LIMS/Empower, and ensure results meet specifications with timely notification of any OOS issues.

The position requires a Bachelor’s degree and at least 3 years in a regulated pharma setting, with strong instrumentation knowledge and a commitment to

Qualifications

• Bachelor’s degree required.
• Minimum 3 years’ experience in a pharmaceutical or regulated environment.

Responsibilities

• Perform routine and non-routine chemical testing per written methodology.
• Conduct qualitative/quantitative analyses using HPLC, GC, UV/Vis, KF, and FTIR.
• Use LIMS and Empower to acquire/process analytical data.
• Compare results to specifications and notify management of OOS/aberrant results.
• Maintain lab equipment and perform calibration/maintenance.
• Create/maintain GMP lab records and demonstrate Right First Time.
• Participate in CAPA and daily team huddles.

Skills

GMP compliance

Regulatory awareness

Method troubleshooting

Instrument maintenance

Education

Bachelor’s degree

Tools

HPLC

GC

Empower

LMS

Job description

Responsibilities:

• Perform routine and non-routine chemical testing of commercial, validation, and stability samples per written methodology.
• Conduct qualitative/quantitative analyses using HPLC, GC, UV/Vis, KF, and FTIR.
• Use LIMS and Empower to acquire/process analytical data.
• Compare results to approved specifications; notify management of OOS/aberrant results.
• Participate in root cause problem solving; provide input for CAPA.
• Maintain lab equipment; perform metrology calibrations and preventative maintenance.
• Create/maintain GMP lab records; demonstrate “Right First Time.”
• Maintain clean/safe environment; follow safety procedures.
• Contribute to continuous improvement, communicate with team/vendors, and participate in daily huddles and 1:1s.

Qualifications:

• Bachelor’s degree required.
• Minimum 3 years’ experience in a pharmaceutical or similar regulated environment.

Skills/Abilities (required):

• Basic knowledge of USP, cGMP, and FDA regulations.
• Use Empower and integrated LMS systems.
• Experience calibrating HPLC/GC systems.
• Ability to maintain/diagnose/work on lab instrumentation.

Also good to have:

• Prioritize work; troubleshoot methods/instruments; independent work with limited supervision.

Benefits (selected):

• Comprehensive health insurance, 401(k) match, Paid Time Off, company-paid life/disability.