Quality Control Analyst II

Our Team, Your Impact
Responsibilities:
- Perform routine and non-routine chemical testing of commercial, validation and stability samples in accordance to written methodology
- Perform qualitative and quantitative analyses using analytical instrumentation such as HPLC, GC, UV/Vis, KF and FTIR
- Utilize electronic laboratory information systems such as LIMS and Empower for acquisition and processing of analytical data
- Analyze data against approved specifications, notifying management of any OOS and aberrant results
- Participate in root cause problem solving during laboratory investigations and provide input for corrective and preventive actions
- Perform routine maintenance on lab equipment as needed
- Perform peer review of laboratory testing, as required

How You’ll Spend Your Day
Compliance and Quality:
- Demonstrate knowledge of USP, cGMP, and FDA regulations
- Create and maintain lab record documentation according to GMPs
- Demonstrate the philosophy of Right First Time
- Maintain a clean and safe work environment and follow safety procedures and policies
Continuous Improvement:
- Provide feedback on systems and processes to promote continuous improvement
- Establish and accomplish annual personal development goals
- Contribute to department and site goals

Your Skills and Experience
Qualifications/Requirements:
- Bachelor’s in a science-related discipline (Chemistry preferred)
- Minimum 3 years of experience in a cGMP laboratory

Also Good to Have (Skills):
- Communicate and collaborate; participate in huddles and one-on-ones
- Prioritize work and work independently with limited supervision
- Troubleshoot methods and instruments using clearly defined alternatives

Accountability:
- Responsible for accurate, timely and compliant execution of assigned projects, analytical testing and related documentation

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