Lab QA Spec 1 at Baylor Scott White Health
College Station, TX 77845, USA -
Full Time


Start Date

Immediate

Expiry Date

14 Dec, 25

Salary

0.0

Posted On

16 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Cap, Texas, It, Regulations

Industry

Pharmaceuticals

Description

PREFERRED EXPERIENCE MLS ASCP CERTIFIED WITH AT LEAST 4 YEARS OF QUALITY EXPERIENCE AND KNOWLEDGE OF CAP REGULATIONS

Here at Baylor Scott & White Health we promote the well-being of all individuals, families, and communities. Baylor Scott and White is the largest not-for-profit healthcare system in Texas that empowers you to live well.

Our Core Values are:

  • We serve faithfully by doing what’s right with a joyful heart.
  • We never settle by constantly striving for better.
  • We are in it together by supporting one another and those we serve.
  • We make an impact by taking initiative and delivering exceptional experience.

JOB SUMMARY

The Lab QA Specialist 1 ensures compliance with institutional and federal regulations. Responsible for proficiency testing, comparing test results, reviewing results, assessing team proficiency, investigating complaints, and managing quality records. Maintains a monitoring and reporting system with documentation to ensure regulatory standards are met.

PREFERRED EXPERIENCE MLS ASCP CERTIFIED WITH AT LEAST 4 YEARS OF QUALITY EXPERIENCE AND KNOWLEDGE OF CAP REGULATIONS

  • EDUCATION - Bachelor’s or 4 years of work experience above the minimum qualification
  • EXPERIENCE - 2 Years of Experience
Responsibilities
  • Is accountable for GLP and GMP quality assurance as defined by Title 21 CFR. Prepares and presents QA reports to hospital management.
  • Sets consistent quality assurance guidelines throughout the sample handling, data, and data reduction process.
  • Sets prescribed quality control procedures and monitors remedial action.
  • Examines quality problems such as shifts and trends, and recommends corrective action.
  • Monitors errors in reported results. Documents complaints, investigations of complaints, corrective actions, and resolutions.
  • Acts as the primary contact for FDA audits and inspections and submits responses to external inspections.
  • Summarizes audit findings for management and makes operational and training improvements based on these needs.
  • Maintains a system for reporting quality assurance and compliance issues to hospital management regularly. Produces ad hoc reports as requested.
  • Writes and maintains current manual of SOPs and making SOPs available for all related team members and external inspectors.
  • Conducts quality assurance training for staff focusing on regulations, monitoring, inspections, SOPs, and other areas of quality assurance periodically.
  • Stay informed about laboratory developments by reviewing literature, attending programs, and joining professional organizations.
  • Performs special quality assurance projects as requested by management or hospital administration.
  • Performs all delegated functions as defined by facility CLIA Director.
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