Sr. Quality Specialist

  • location: Redwood City, CA
  • type: Permanent
  • salary: $70,000 - $90,000 per year
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job description

Sr. Quality Specialist

job summary:
Seeking a Senior Quality Specialist to support our client's quality system requirements, and conformance to regulatory requirements. This role will focus on leading and providing support to major projects, investigations, training and CAPAs. This role will drive for efficiency in procedures and practices for the Clinical Laboratory and identify opportunities for continual improvement.

location: Redwood City, California
job type: Permanent
salary: $70,000 - 90,000 per year
work hours: 9 to 5
education: Bachelors
  • Owns all activities related to the clinical laboratory, including activities related to pre-analytical, analytical and post analytical phases
  • Supports clinical laboratory related issues and works closely to determine root cause and potential preventative/corrective actions
  • Ensures that training and competency for the clinical laboratory is maintained
  • Reviews and approves any laboratory validation life cycle documentation including, protocols and reports
  • Performs trending analysis (Quality Metrics) on a routine basis by identifying, generating and publishing metrics and reports related to the Quality System performance and reporting anomalies to management
  • Ensures that the laboratory licenses are maintained
  • Represents Quality at cross functional meetings
  • Supports other routine Quality processes such as document control, employee training, investigations, equipment qualifications, internal audits, as required
  • Serve as a Subject Matter Expert for Laboratory Operations internal or external matters. Participates in inspection readiness activities and is significantly involved in inspections by regulatory agencies.
  • Develops and maintains organized records that demonstrate compliance to all company processes, regulations, and the company's QMS
  • Ensures that all policies, procedures, and records are reviewed and approved
  • Executes special projects as assigned
  • Reports and documents all concern of test quality and/or safety to the Supervisor or Safety Officer, as applicable.
  • Bachelor's degree in a scientific discipline
  • 5+ years of quality experience in a Clinical Research laboratory (CLIP/CAP certified)
  • Experience in compliance with quality standards in a regulated molecular laboratory (e.g. CLIA, CAP, NYSDOH, etc.)
  • Working knowledge of GCP, ISO 15189 preferred
  • Experience with utilizing a Laboratory Information Management System (LIMS) is preferred
  • Experience with Microsoft Office Suite
  • Effective verbal and written communication skills and ability to share and receive information from all levels of the organization
  • Ability to work effectively in a team environment
  • Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
  • Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
  • Proven attention to detail
  • High degree of initiative and self-motivation
  • Drive for results and continual improvement - ensure procedures and processes are in place that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvement
skills: Quality control, Quality Assurance, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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