GxP - QC Lab Analyst

Job Title: QC Lab Analyst

Location: Hmapshire

Department: Quality Control

Reports To: QC Lab Manager

Position Summary:

The QC Lab Analyst is responsible for performing basic analysis, evaluation, and release of raw materials, mass, and/or cosmetic finished goods in compliance with specifications and standards. This includes conducting environmental monitoring testing, validating results, and performing investigations for Out of Specification (OOS) results. The role also involves providing feedback for improvements, updating SOPs, and training staff on new technical procedures. The QC Lab Analyst ensures the highest quality standards are maintained before materials are shipped or used in manufacturing.

Key Responsibilities:

Execution of QC Lab Testing (75%)

• Monitor Critical Control Parameters such as lab process water, pH, and balance through daily equipment verification checks.

• Perform routine and non-routine analysis of raw materials, mass, and finished goods, including sample preparation, testing, analysis, and reporting. This includes entering results into SAP/LIMS and preparing Certificates of Analysis (CoA).

• Conduct environmental monitoring testing and validation in compliance with regulatory standards.

• Ensure complete and accurate documentation for testing procedures and results.

• Collaborate with the Lab Coordinator to retain or discard samples, and ensure proper archiving of lab documents.

Testing Data Review and Release (Varies by site)

• Review supporting test data and results, including sample preparation records, logbooks, calculations, and data sheets.

• Enter test results into SAP/LIMS and release raw materials, non-OTC mass, and cosmetic finished goods in the laboratory.

Investigation and Problem Solving (15%)

• Identify quality-related issues and propose opportunities for process improvements.

• Conduct Phase 1 Out of Specification (OOS) investigations under the guidance of senior lab analysts.

• Evaluate consumer complaints and Quality Inquiries to support QC decision-making and corrective actions.

SOP Development and Training (10%)

• Develop and update Standard Operating Procedures (SOPs) for QC testing processes and protocols.

• Provide training on new technical procedures to lab staff, ensuring continuous improvement and adherence to quality standards.

Key Skills & Qualifications:

• Bachelor's degree in a related scientific field (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences) or equivalent experience.

• Previous experience in a Quality Control or laboratory setting, preferably in the pharmaceutical, cosmetic, or manufacturing industries.

• Familiarity with laboratory testing, sample preparation, and data entry (SAP/LIMS or similar).

• Strong attention to detail and ability to follow strict testing protocols and SOPs.

• Excellent problem-solving skills with the ability to identify issues and suggest improvements.

• Good communication skills and ability to work collaboratively within a team.

• Ability to work independently with minimal supervision while meeting deadlines and managing priorities.

Additional Information:

• Position requires occasional participation in investigations and troubleshooting OOS results.

• Training will be provided on new technical procedures, as needed.

• The role will involve regular interaction with other departments, including manufacturing and management.