Clinical and Scientific - Quality Control Chemist I

Job Title: Quality Control Chemist I
Job Location -John Creek, GA
Duration - 24 Months

Role: Associate I, Quality Control Lab – Chemistry

Performs routine and non-routine analytical testing of raw materials, in-process samples, intermediates, and finished goods to support material release for production use. This role ensures testing activities are executed in accordance with approved SOPs, quality standards, and regulatory requirements while supporting production and project timelines. The associate is responsible for completing accurate and compliant documentation related to analytical testing and product inspection, and for entering data into electronic systems such as SAP and LIMS. Results and material disposition are communicated clearly and timely to internal and external stakeholders.

This role ensures inspections and testing activities are completed in alignment with SOPs, quality expectations, and the production plan. The associate communicates defects, atypical results, and quality concerns to laboratory supervision and Quality Assurance to support investigations and corrective actions. The Associate I maintains strict adherence to data integrity practices, including ALCOA principles, and is responsible for reviewing and verifying test data for accuracy, completeness, and compliance. Timely reporting of results is critical to support product release, project deliverables, and business needs.

The role also participates in day-to-day laboratory operations, including safety, quality initiatives, 5S activities, and required training. The associate supports continuous improvement projects within a defined scope and demonstrates compliance with ISO, FDA, and GMP requirements. A strong commitment to promoting a culture of quality, safety, and compliance is essential.

Experience

• Experience working in a regulated Quality Control lab using instruments such as HPLC, pH meter, titrator, and particle size analyzer.

Required Skills

• GMP Practice: Understanding of GMP laboratory operations. Ability to follow detailed procedures and work independently.
• Analytical Skills: Strong analytical abilities to identify and troubleshoot quality issues. Ability to interpret and analyze data.
• Problem-Solving Skills: Basic troubleshooting and problem-solving abilities.
• Communication Skills: Strong communication and teamwork skills. Effective communication with team members, management, and external vendors to ensure alignment on quality standards.
• Attention to Detail: Strong attention to detail for identifying potential quality issues and ensuring documentation accuracy.
• Time Management: Effective time management and prioritization skills.

Preferred

• Experience with LabVantage or similar LIMS, Empower 3, or similar data acquisition systems.

Bachelor's Degree in Chemistry