Quality Control Associate I

Job Description

Job Summary:

• The job responsibility within the PTDA Bioassay US Testing Group is to perform biochemical/immunological and cell-based assays in support of clinical and to-be-marketed products.
• The candidate will support process development, product characterization, stability, and lot release testing with established procedures in a cGMP environment.
• Responsibilities include, but are not limited to, compliance review and release of assay data (electronic and paper-based), preparing reagents, presenting results, and monitoring assay quality.
• Expectations include Good Documentation Practices, demonstrating ALCOA+ principles, data integrity, routine lab maintenance, supporting 5S, and following EHS safety practices.

Requirements:

• B.S. in Biological Sciences with at least 1-2 years of relevant experience in Quality Control.
• Hands-on experience with performing immunological or cell-based assays.
• Experience with aseptic cell culturing and cGMP knowledge is required.
• Ability to work independently as well as with a team, handle multiple projects, demonstrate initiative while maintaining exceptional attention-to-detail.
• Demonstrate effective verbal and written communication skills in a fast paced environment.
• Required proficiency in computer applications, data management, and electronic documentation systems.
• Prior experience with GxP-compliant systems such as global SoftMax Pro, Single LIMS, and Veeva QMS is highly preferred.

Interview Format:

Two rounds:

• On-site (30 minutes).
• On-site (Panel) – 60 minutes.