Analytical Chemist II

RXinsider LTD.; Columbia, Northern (SC, KY); Hybrid; USD 60,000 - 75,000; Full time

Job summary

RXinsider LTD. in Columbia, SC is seeking a Chemist to support quality control testing and R&D by conducting laboratory analyses on raw materials, in-process materials, finished products, and stability samples according to approved methods.

You will apply GDP and cGMP practices, analyze data, review notebooks, train junior chemists, troubleshoot instruments, and contribute to investigation documentation as needed.

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 SOPs, Forms, and Specifications independently with management guidance.
• Ability to lead root cause analysis for laboratory investigations for OOS and atypical QC results.

Responsibilities

• Conduct routine and complex laboratory testing for raw materials, in-process materials, finished product samples, and stability samples.
• Perform testing using best-practice analytical techniques and follow GDP and cGMP requirements.
• Accurately analyze and interpret data using specifications and test methods.
• Peer review notebooks and verify raw data to support sample release.
• Enter data using reporting systems and release forms.
• Mentor and train Chemists to support laboratory operations.
• Assist in troubleshooting equipment and analyses.
• Support investigation documentation as needed.

Skills

Analytical skills

cGMP knowledge

Data analysis

SOPs writing/reading

Communication

Education

BS or MS in Chemistry/Biochemistry or related field

Tools

FT-IR

UV/Vis spectroscopy

HPLC

GC

ICP testing

Job description

Job Purpose:

The purpose of this position is to support quality control testing and research and development activities as needed by conducting laboratory testing for raw materials, in-process materials, finished product, and stability samples in accordance with approved analytical methods.

Essential Duties And Responsibilities

• Conduct routine and complex laboratory testing for raw materials, in-process materials and samples, finished product samples, 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.

Supplemental Functions

• Relies on instructions and pre-established guidelines to perform job functions.
• Performs other similar duties as required.
• Works under supervision.

Requirements

Job Specifications and Qualifications:

Knowledge & Skills

• 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.

Education/Experience

• BS or MS in Chemistry, Biochemistry, or related field required with 2-5 years of pharmaceutical experience preferred. Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate.
• Experience with conducting analysis by FT-IR, UV/Vis spectroscopy, and wet chemistry techniques is required.
• Highly skilled in advanced techniques such as HPLC, GC, and ICP testing, needing little or no guidance and supervision.

Working Conditions / Physical Requirements

• This position requires bending, typing, lifting (up to 40 lbs.), standing, sitting and walking throughout the facility.
• This position encounters the following environmental factors: hazardous materials including HPLC solvents, chemical reagents, acids, and other non-specified hazardous materials that are project specific.
• This position requires safety glasses and other non-specified personal protective equipment to be worn as necessary.