Quality Control Analyst II

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.

Application:
- Apply through the internal career site on Twist.