Quality Control Associate I

Quality Control Associate I
Location: South San Francisco, CA- Onsite
Duration: 12 Months+
Shift: 1st Shift
Pay $25-$29/HR ON W2

Job Description

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.

Qualifications:

• 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

Working Model:

• On-site (5 day a week)

Interview Format:

• Two rounds
  1 - On-site (30 minutes)
  2 - On-site (Panel) - 60 minutes