Job Details

Job Overview

The Quality Control Associate will support the PTDA Bioassay US Testing Group by performing biochemical, immunological, and cell-based assays in support of clinical and commercial products. This role operates in a cGMP-regulated laboratory and supports process development, product characterization, stability, and lot release testing using established procedures.

Key Responsibilities

• Perform biochemical, immunological, and cell-based bioassays
• Support process development, product characterization, stability, and lot release testing
• Review, verify, and release assay data (electronic and paper-based)
• Prepare reagents and maintain assay readiness
• Present assay results and monitor assay performance and quality
• Follow Good Documentation Practices (GDP) and ALCOA+ data integrity principles
• Perform routine laboratory maintenance and support 5S initiatives
• Comply with EHS safety requirements and cGMP standards

Required Qualifications

• B.S. in Biological Sciences or related field
• 1–2 years of relevant experience in Quality Control
• Hands-on experience with immunological and/or cell-based assays
• Experience with aseptic cell culture
• Working knowledge of cGMP environments
• Ability to work independently and collaboratively in a fast-paced setting
• Strong attention to detail and ability to manage multiple priorities
• Effective written and verbal communication skills

Technical & Systems Skills

• Proficiency with computer applications, data management, and electronic documentation
• Experience with GxP-compliant systems such as SoftMax Pro, LIMS, and Veeva QMS (preferred)