Position Summary

The QC Analyst II will perform analytical testing and data review in support of late-stage clinical and commercial small molecule and biosimilar products within cGMP-compliant laboratories. This person will effectively perform and troubleshoot a range of techniques, including HPLC, SDS-PAGE, ELISA, capillary electrophoresis, and cell-based bioassays. 

Essential Duties & Responsibilities

• Perform analytical testing to support in-process, release, raw material, and stability programs.
• Ensure compliance with cGMP regulations, quality systems, and applicable ICH/regulatory guidelines.
• Participate in the investigation and documentation of Out-of-Specification (OOS) results, deviations, and corrective and preventive action (CAPA) plans.
• Collaborate across departments to support project advancement, equipment maintenance, and the creation of technical documents and reports.
• Conduct root cause analyses as part of laboratory investigations and assist in closing quality events.
• Support regulatory and internal audits as needed.
• Perform additional duties as assigned.
• Adhere to all company policies and procedures.

Position Requirements and Qualifications

Education:

• Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field 
• Minimum of 3+ years of experience

Experience:

• Hands-on experience working in a cGMP-compliant laboratory.
• Proficient in analytical techniques such as HPLC, SDS-PAGE, ELISA, capillary electrophoresis, and cell-based assays.
• Familiarity with preparing regulatory submissions and data packages for interactions with regulatory agencies (e.g., FDA).

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH