Analytical Chemist I

Nephron Pharmaceuticals Corporation; Columbia, Northern (SC, KY); Hybrid; USD 52,000 - 75,000; Full time

Job summary

Nephron Pharmaceuticals Corporation is seeking a Quality Control Analyst to support routine laboratory testing for raw materials, in-process materials, finished product, and stability samples. The role emphasizes adherence to approved analytical methods and GDP/cGMP standards.

The candidate should have a BS or MS in Chemistry or related field with 0–3 years of pharmaceutical experience, and hands-on experience with FT-IR, UV/Vis, HPLC, and GC.

Qualifications

• Requires BS or MS in Chemistry, Biochemistry, or related field with 0–3 years pharmaceutical experience preferred.
• Experience with FT-IR, UV/Vis spectroscopy, and wet chemistry techniques is required.
• Experience with HPLC and GC is preferred; knowledge of analytical methods and specifications is essential.

Responsibilities

• Conduct routine laboratory testing for raw materials, in-process materials, finished product, and stability samples.
• Perform data analysis and interpretation using approved specifications and methods.
• Peer review notebooks and verify raw data to support sample release and data integrity.
• Enter data into reporting systems and completion of release forms.
• Follow GDP and cGMP requirements and maintain compliance with SOPs.

Skills

Strong analytical skills

Problem-solving ability

Attention to detail

cGMP knowledge

USP standards knowledge

SOPs reading/writing

Effective communication

Continuous improvement mindset

Education

BS or MS in Chemistry/Biochemistry/related field

Tools

FT-IR

UV/Vis spectroscopy

HPLC

GC

Job description

Description

Job Purpose: The purpose of this position is to support quality control testing and research and development activities as needed by conducting routine 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 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.

Supplemental Functions:

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

Requirements

Knowledge & Skills:

• Strong analytical skills, problem-solving ability, and attention to detail.
• An understanding of cGMP regulations pertaining to laboratory controls and knowledge of USP standards.
• Ability to read, understand, review, and update Standard Operating Procedures, Forms, and Specifications and assist in designing new procedures as necessary under management guidance.
• Ability to perform testing for laboratory investigations for OOS and atypical QC test results under management guidance.
• Ability to effectively communicate within Chemistry Laboratory Staff and Management.
• Acknowledge and identify continuous improvement opportunities in all work activities.
• 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 0-3 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.
• Experience in more advanced techniques such as HPLC and GC is preferred.

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.