LabCorp Job - 32641269 | CareerArc
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Company: LabCorp
Location: South San Francisco, CA
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

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).

 

Responsibilities:

  • 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
Requirements
  • 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.)
Shift 1 Schedule Monday-Friday 9 AM-5:30 PM


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