Monogram, part of LabCorp's Specialty Testing Group, is seeking a Quality Coordinator to join its team in South San Francisco! This position will be a key contributor in the continuous improvement and management to Monogram's Part 820 / 13485 compliant Quality Management System (QMS).
Note -- this position will be onsite, not remote. Monogram and LabCorp are essential businesses.
- Development and continuous improvement of Monogram's Quality Management System under the guidance of the QA management
- Maintenance of Monogram's document control system; processing and technical editing of controlled documents (e.g. SOPs, Forms, Policies) including project/product-specific documents.
- Participation in QA group project planning and goal setting. May also provide training and support to other QA groups, as assigned.
- Participate in the development of Quality Initiatives and the execution of Monogram's Quality programs. These activities will include participation in internal audits, client or sponsor audits, personnel training files audit and trending/reporting of quality metrics.
- Review and tracking of nonconformance data and CAPA action items. Assist in the investigations and determination of root cause.
- Primary support for the Monogram Audit (Host) Team; coordinating with other functional areas to obtain materials, documents, records and other similar references requested during audits and inspections.
- Maintenance of other Quality systems and processes as designated by QA management
- Associates or B.S. degree in a scientific discipline
- 1-3 years of hands-on Quality or related experience in a regulated environment, preferably in Part 820 QSR, ISO 13485, GxP or CAP/CLIA
- Knowledge of US GxP compliance regulations and industry practices, as well as EU GxP requirements
- Must possess strong technical documentation skills
- Ability to function independently within a cross-functional team and address a variety of moderate to complex problems
- Excellent (written and verbal) communication and interpersonal skills, solid organizational skills, and ability to contribute to a collaborative, flexible work environment
- Proficiency in computer applications (MS Word, MS Excel, etc.)
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.Shift 1 Schedule Monday-Friday 9 AM-5:30 PM
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