Quality Control Chemistry Analyst

Role Summary

Location: Framingham, MA. The Quality Control Chemistry Analyst supports Framingham Manufacturing by performing testing and ensuring QC data quality for release of products. The role includes reviewing QC data for adherence to procedures, supporting QC method investigations and corrective actions, and collaborating with cross-functional teams to meet shared goals. This position operates within a digitalized bio-manufacturing environment and reports to the QC Manager.

Responsibilities

• Review QC Data for compliance to procedures and specifications
• Experience in HPLC/UPLC, Gel Electrophoresis, Spectrophotometric assays
• Collaborate on Quality Control method investigation and corrective action implementation
• Work effectively with others to achieve shared goals
• Reports to the QC Manager

Qualifications

• Required: Bachelor's Degree in Life Sciences with 6 years’ experience in a cGMP lab environment, or Master's Degree in Life Sciences with 4 years’ experience in a cGMP lab environment.
• Experience in GMP Pharmaceutical/Biologics
• Experience with HPLC, Gel Electrophoresis, UV-Vis Spectroscopy, or wet Chemistry
• Experience with Empower software
• Familiarity with USP and global compendia requirements
• Knowledge and experience with discrepancy investigation and lot disposition to meet regulatory requirements

Skills

• Proficient with Outlook, Microsoft Word and Excel, and lab-based data management systems
• Experience with Empower software

Education

• Life Sciences degree (Bachelor's required; Master's preferred)