Planet Pharma
Overview
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 Compliance review and release of assay data (electronic and paper-based), preparing reagents, presenting results, and monitoring assay quality.
Expectations 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.
Seniority Level Associate
Employment Type Contract
Job Function Science
Industries Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
Location Brisbane, CA
#J-18808-Ljbffr
Responsibilities Compliance review and release of assay data (electronic and paper-based), preparing reagents, presenting results, and monitoring assay quality.
Expectations 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.
Seniority Level Associate
Employment Type Contract
Job Function Science
Industries Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
Location Brisbane, CA
#J-18808-Ljbffr