Chemist - I

WorkLlama, Inc.; Wilson (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

WorkLlama, Inc. is seeking a Quality Control Laboratory Analyst to perform routine analytical testing of pharmaceutical drug substances and products in a GMP laboratory, focusing on dissolution, content uniformity, and identity testing.

You will document results, support investigations, assist with instrument troubleshooting, and participate in continuous improvement initiatives, daily tier meetings, and updated SOPs.

Qualifications

• BS in Chemistry, Biology, Engineering, or related STEM field.
• Working knowledge of routine lab equipment and cGMP/cGLP.
• Proficiency with Microsoft Office (Word, Excel, Outlook).

Responsibilities

• Perform routine analytical testing on drug products and substances in a GMP lab (dissolution, assay/degradate, content uniformity, identity).
• Document and report testing results in compliance with regulatory guidelines (cGMP/cGLP).
• Troubleshoot analytical instrumentation to maintain readiness.
• Contribute to lab investigations and root-cause analysis for out-of-spec results.
• Participate in daily tier meetings to review targets and quality metrics.
• Apply Lean/CI principles (5S, Kaizen, Standard Work) to improve workflows.
• Assist with SOP updates and drafting quality notifications.

Skills

HPLC

Dissolution testing

cGMP/cGLP

Documentation

Root cause analysis

Kaizen / CI

SOP drafting

Tier management

5S

QA investigations

Education

B.S. in Chemistry / Biology / Engineering

Tools

Empower

Labware/LIMS

Karl Fischer

pH meters

UV-Vis

FTIR

NIR

Job description

The Quality Control Laboratory Analyst performs routine analytical testing, precise documentation, and reporting for pharmaceutical drug substances and drug products in a compliant GMP laboratory environment. Responsible for executing assays such as dissolution, content uniformity, and identity testing, this role plays a key part in maintaining product quality and operational efficiency. Additionally, the role supports continuous improvement initiatives, participates in daily tier meetings, and assists with laboratory investigations, instrument troubleshooting, and technical documentation.

Responsibilities

• Perform routine laboratory analytical testing on pharmaceutical drug products and drug substances, including dissolution, assay/degradate, content uniformity, and identity testing in a GMP laboratory.
• Execute accurate documentation and reporting of all testing results in full compliance with regulatory, cGLP, and cGMP guidelines.
• Conduct simple troubleshooting of analytical laboratory instrumentation to ensure continuous operational readiness.
• Participate actively in laboratory investigations and root cause analysis for out-of-specification or anomalous results.
• Engage in daily tier process meetings to review operational targets, quality metrics, and lab performance.
• Apply continuous improvement principles (e.g., 5S, Kaizen, Hoshin, Standard Work) to enhance laboratory efficiency and workflows.
• Assist with technical writing, including updating standard operating procedures (SOPs) and drafting quality notifications.

Education

• Bachelor of Science (B.S.) degree in Chemistry, Biology, Engineering, or a related STEM field.

Experience

• Working knowledge of routine laboratory equipment operations, such as Karl Fischer, pH meters, conductivity meters, UV-Vis, HPLC, and dissolution apparatus.
• Core understanding of regulatory compliance, cGLP principles, and cGMP standards within a pharmaceutical environment.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook).
• Preferred hands-on experience operating advanced instrumentation, including HPLC, dissolution apparatus, FTIR, and NIR.
• Preferred experience utilizing chromatography data systems (Empower) and Laboratory Information Management Systems (Labware/LIMS).
• Preferred background in executing root cause analysis, technical writing, continuous improvement methodologies, and participating in Tier management processes.

Additional Information

• Compliance Standards: Operating strictly within cGMP and cGLP framework to ensure regulatory audit readiness.
• Continuous Improvement Focus: Utilizes Lean/CI frameworks like 5S, Kaizen, and Standard Work to optimize daily analytical testing operations.