Quality Control Analyst

The QC Analyst will support late-stage clinical and commercial programs by performing and reviewing analytical testing in a cGMP-regulated environment. This position requires strong technical expertise in protein chemistry and proficiency with a range of analytical methods to ensure product quality and regulatory compliance.

• Conduct analytical testing for in-process, raw materials, release, and stability programs in accordance with established SOPs and regulatory requirements.
• Ensure full compliance with cGMP, ICH guidelines, and internal Quality Systems.
• Participate in and support investigations related to Out-of-Specification (OOS) results, deviations, and development of CAPA plans.
• Collaborate cross-functionally to support project execution, equipment qualification, and documentation of analytical data and reports.
• Assist in regulatory inspections and internal audits by providing data, documentation, and subject matter expertise.
• Maintain a high level of data integrity and ensure timely, accurate completion of laboratory documentation.
• Carry out additional responsibilities as needed, in alignment with company policies and procedures.

• Minimum of 3 years of hands-on experience in a GMP-compliant QC laboratory environment.
• Proficient in key analytical techniques including:
• HPLC
• SDS-PAGE
• ELISA
• Capillary Electrophoresis

• Bachelor’s degree in Biotechnology, Biochemistry, Chemistry, or a closely related field.

• Seniority level:
  Associate
• Employment type:
  
  Full-time
• Job function:
  Science
• Industries:
  Pharmaceutical Manufacturing