cGMP QC Analyst: Drug Product Testing & Analysis

Katalyst CRO; Wilson (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Katalyst CRO in the United States seeks a chemistry analyst to perform a variety of chemical analyses and GMP review in a cGMP laboratory, in accordance with GLP, DEA and company policies.

You will enter data into the laboratory information system, operate and maintain analytical instruments (HPLC, GC, Dissolution, UV/Vis, etc.), and help ensure safe, organized work areas while supporting fellow team members.

Qualifications

• BA or BS in Chemistry or closely related science.
• Minimum of 1 year relevant experience preferred.
• Understanding of analytical technology (HPLC, GC, Dissolution, Automation, or Spectroscopy UV/Vis, NIR, IR, or AA/AE).
• Physical and Environmental requirements as listed: vary positions, lifting up to 20 pounds, instrument maintenance, and safety practices.

Responsibilities

• Perform routine testing (dissolution, assay/degradant, content uniformity and ID) of drug products in a cGMP laboratory.
• Complete all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
• Enter data into laboratory information system and document all necessary information clearly and concisely.
• Operate and maintain analytical instrumentation and perform basic troubleshooting.
• Communicate openly within the group to optimize resources and efficiency.
• Aid other group members as required.
• Maintain equipment and working areas with good safety and housekeeping practices.
• Re-stock chemicals and consumables used in analysis.
• Perform other related assignments as required.

Skills

Analytical chemistry

HPLC

GC

Dissolution testing

Spectroscopy UV/Vis

Laboratory automation

Education

BS in Chemistry

Tools

LIMS

Job description

Katalyst CRO in the United States seeks a chemistry analyst to perform a variety of chemical analyses and GMP review in a cGMP laboratory, in accordance with GLP, DEA and company policies.

You will enter data into the laboratory information system, operate and maintain analytical instruments (HPLC, GC, Dissolution, UV/Vis, etc.), and help ensure safe, organized work areas while supporting fellow team members.