Analytical Chemist II — QC & R&D Support

RXinsider LTD.; Columbia (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

RXinsider LTD. in the United States (Columbia, SC) seeks an analytical chemist to support quality control testing and research and development activities.

You will conduct routine and complex laboratory testing for raw materials, in-process materials, finished products, and stability samples following approved analytical methods. You will apply GDP and cGMP standards, analyze data, peer-review notebooks, and assist in troubleshooting instrumentation while mentoring junior chemists and

Qualifications

• Strong analytical skills, problem-solving ability, and attention to detail.
• Sound understanding of cGMP regulations pertaining to laboratory controls and thorough knowledge of USP and compendia standards.
• Ability to read, understand, review, and update Standard Operating Procedures, Forms, and Specifications and assist in designing new procedures as necessary independently, subject to management guidance.
• Ability to perform testing and lead root cause analysis for laboratory investigations for OOS and atypical QC test results, subject to management guidance.
• Ability to effectively communicate within Chemistry Laboratory Staff and Management, as well as other departments.
• Acknowledge and identify continuous improvement opportunities in all work activities. Initiate and follow through to implement, track, and achieve on-time completion of testing to support sample release to meet business needs and demands.
• Ability to effectively use a multitude of resources to perform job functions accurately.

Responsibilities

• Conduct routine and complex laboratory testing for raw materials, in-process materials, finished product, and stability samples in accordance with approved analytical methods.
• Conduct and execute laboratory work and testing using best-practice analytical techniques and follow laboratory GDP and cGMP requirements
• Accurately analyze and interpret data using appropriate specifications and test methods.
• Accurately peer review notebooks and verify raw data to support sample release, including data generated in electronic software systems.
• Accurately enter data using appropriate reporting systems and release forms.
• Mentor and train Chemists as needed to support laboratory operations.
• Assist in troubleshooting equipment, analyses, etc.
• Support and contribute to investigation documentation, as needed.

Skills

Analytical skills

Problem solving

Attention to detail

cGMP knowledge

USP standards

SOPs and documentation

Root cause analysis

Communication

Continuous improvement

Team mentoring

Education

BS or MS in Chemistry/Biochemistry

Tools

FT-IR

UV/Vis spectroscopy

HPLC

GC

ICP testing

Wet chemistry

Job description

RXinsider LTD. in the United States (Columbia, SC) seeks an analytical chemist to support quality control testing and research and development activities.

You will conduct routine and complex laboratory testing for raw materials, in-process materials, finished products, and stability samples following approved analytical methods. You will apply GDP and cGMP standards, analyze data, peer-review notebooks, and assist in troubleshooting instrumentation while mentoring junior chemists and