Location South San Francisco, CaliforniaJob ID 19-86738
Monogram, part of LabCorp's Specialty Testing Group is seeking a Quality Systems Analyst/Specialist to join its team in South San Francisco! The Quality Systems Analyst position will be key to Monogram's development of a sustainable and robust Companion Diagnostic (CDx) business that includes Single-Laboratory-Use assay development, Manufacturing and CLIA laboratory operations that will support all phases of CDx product development and commercialization in the US and select markets outside of the US.
As a member of the Quality department, this position will provide support for Monogram's Quality Management System (QMS) and Companion Diagnostic (CDx) Assay development efforts for FDA compliance (Part 820 QSR). This position will also require routine coordination with multidisciplinary functional and product-specific project teams dedicated to building and improving Monogram's QMS while providing products and services to our Pharma partners. The ideal candidate will have previous experience working within FDA, GMP or CLIA regulated environment. Responsibilities:
Manage and provide continuous improvement of Monogram's Quality Management System under the guidance of the QA Manager or Director
Ensure paper and electronic quality systems in compliance with QSR, CLIA, GxP and other applicable regulations and guidelines
Responsible for the management and maintenance of Monogram's document control system; processing and technical editing of QA controlled documents (e.g. SOPs, Forms, Policies) including project/product-specific documents
Provide trending and analysis of key quality metrics including nonconformance data.
Review and track CAPA action items. Assist with the investigations and determination of root cause
Maintain and manage the design/device change control system
Implement, administer and manage training programs
Associates degree in a scientific discipline required. BA/BS degree preferred
3-5 years of hands-on Quality experience in a regulated environment required
Previous experience working within one of the following regulated environments required: FDA, Part 820 QSR, GMP or CLIA
Knowledge of US GxP compliance regulations and industry practices, as well as EU GxP requirements
Previous experience with MasterControl, or a similar Electronic Data Management System (EDMS) highly desired
Monogram Biosciences, Inc.(a wholly-owned subsidiary of LabCorp), is a leader in developing and commercializing innovative diagnostic products to help guide and improve the treatment of HIV, HCV, and other viral illnesses, as well as cancer and other diseases. Monogram's services enable health care providers to optimize treatment regimens for their patients. Monogram also supports pharmaceutical companies in developing new and improved antiviral therapeutics and vaccines and targeted cancer therapeutics. Located in South San Francisco, Monogram provides an innovative and flexible work environment, where you will have the opportunity to be part of pioneering new diagnostics technologies.