Monogram, part of LabCorp's Specialty Testing Group, is seeking a Quality Specialist/Analyst 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).
- Development and continuous improvement of Monogram's Quality Management System under the guidance of the QA Manager or Director
- Management of Monogram's document control system; processing and technical editing of controlled documents (e.g. SOPs, Forms, Policies) including project/product-specific documents
- Management of the design / device change control system
- Perform trend analysis of key quality metrics including nonconformance data. Review and track 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
- 4-6 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, FileMaker Pro, etc.)
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