Quality Control Chemistry Analyst

Role Summary

Quality Control Chemistry Analyst based in Framingham, MA. QC Chemistry performs testing in support of Framingham Manufacturing, contributing to bio-manufacturing efforts and ensuring compliance with procedures and specifications.

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

• Basic Qualifications: Bachelor's Degree in Life Sciences discipline 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: Proficient in Outlook and Microsoft Word and Excel and lab-based data management systems
• 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