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Quality Assurance Analyst- Central Lab Services

Quality Assurance Analyst- Central Lab Services

Exton, PA (Corporate)

Job Title: Quality Assurance Analyst – Central Lab Services

Reports To:  Vice President, Global Central Lab Services

Remote Position:  No

POSITION OVERVIEW:

  • The Quality Assurance Analyst – Central Lab Services will be responsible for supporting management in developing and maintaining pertinent quality documentation for the clinical laboratory services at Frontage Laboratories, Inc. Such tasks include writing and revising Standard Operating Procedures and Policies, monitoring quality metrics, developing and maintaining training and competency documentation, managing documentation for HIPAA compliance and IT compliance, and assisting with compliance audits.

 

  • Responsibilities:
    • Writing and revising Standard Operating Procedures and Policies related to Quality and Compliance
    • Assess overall compliance with protocols, SOPs, policies, and applicable regulations
    • Participate in improvement opportunities and non-conforming event management
    • Perform regulatory review of standard operating procedures
    • Prepare for and participate regulatory and accrediting agency inspections (CAP, PA DOH, FDA, and ISO)
    • Prepare for and participate client audits
    • Monitor metrics, including root cause analysis and review of corrective action and preventive measures
    • Support Quality Management System
    • Support HIPAA Compliance and managing HIPAA-related documentation
    • Support IT Compliance and managing IT-related documentation
    • Monitor the progress of implementation and subsequent use of document control system (ZenQMS)
    • Support the Change Control Process
    • Monitor and respond to other quality assurance issues as assigned
    • Serve as a source on regulatory issues and compliance

“Must Have”                                               

  • A/B.S. in Biology, chemistry, or related scientific disciplines
  • Minimum of 2 years’ experience assisting with or managing a quality management system in a regulated environment; clinical laboratory experience highly desired
  • Working knowledge of FDA GCP, CLIA Regulations, HIPAA, CAP checklist (or any combination) will be highly desired

 

 ESSENTIAL SKILLS include the following.

The skills listed below are representative of those that are required to perform this job successfully. Interview questions should be designed to verify/validate that the candidate possesses the  skills specified below.

  • High level of accountability with self and others
  • Hands-on approach with a desire to teach others
  • Track record of challenging the status quo
  • Team and action-oriented
  • Problem-solving
  • Priority setting
  • Timely decisions
  • Strong leadership

 

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