Management and continuous improvement of Quality Management System under the guidance of the QA Manager or Director.
Management and continuous improvement of paper and electronic quality systems in compliance with QSR, CLIA, GxP and other applicable regulations and guidelines.
Management and maintenance of document control system; processing and technical editing of QA controlled documents (e.g. SOPs, Forms, Policies) including project/product-specific documents.
Trending and analysis of key quality metrics including nonconformance data.
Review and tracking of CAPA action items.
Assisting in the investigations and determination of root cause.
Management and maintenance of the design/device change control system.
Implementation and management of training programs.
Primary support for the Audit (Host) Team; coordinating with other functional areas to obtain materials, documents, records and other similar references requested during audits and inspections.
The CDx QA Analyst will be reporting to the CDx QA Manager or Director of QA and will also require routine coordination with multidisciplinary functional and product-specific project teams dedicated to building and improving QMS while providing products and services to our Pharma partners.
Working Conditions:
Exposure to specimens and material considered to be infectious and/or hazardous.
Use and wearing of protective garments and equipment.
Travel up to <5%, as applicable.
Qualifications:
Associate or B.S. degree in a scientific discipline with 4-6 years of hands-on Quality or related experience in a regulated environment, preferably in Part 820 QSR, ISO 13485, IVD/IVDR, 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.).
Seniority level
Entry level
Employment type
Contract
Job function
Quality Assurance
Industries
Information Technology & Services
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