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QA Validation Technician I

Tampa, FL 33634

Posted: 05/29/2025 Employment Type: Contract Job Category: Quality Job Number: 4461

Job Description

The QA Validation Technician I carries out the practical work in the laboratory including method development, method validation and trouble shooting. Takes over responsibility for the QC part of projects. Perform required testing on raw materials, intermediates and finished products. Support QC chemist to provide the method technology transfer and project preparation work, make sure the project runs on time and smoothly.

Responsibilities:
  • Transcribe laboratory data from worksheets, logbooks, and instrument outputs into electronic systems and official records with high accuracy and attention to detail, ensuring compliance with cGMP and data integrity principles.
  • Review, analyze, and trend laboratory data from environmental, raw material, in-process, and final product testing to ensure conformance with specifications and regulatory requirements.
  • Ensure accurate, timely, and compliant documentation of all data in accordance with cGMP and Standard Operating Procedures (SOPs).
  • Maintain databases and electronic records for laboratory data, ensuring data integrity and regulatory compliance.
  • Author, revise, and review SOPs, data review templates, and protocols to support consistent data handling practices.
  • Partner with QC laboratory staff to investigate data deviations and support root cause analysis and CAPA development.
  • Provide data reports, summaries, and metrics to support production, investigations, and continuous improvement initiatives.
  • Reviews GDP and date integrity to ensure that review and approval of all GxP data generated for projects are managed and evaluated as described in relevant protocol, SOP and regulatory requirements.
  • Support method and equipment validation through data compilation and statistical evaluation.
  • Participate in internal, customer, and regulatory audits by preparing data packages and responding to data-related inquiries.
  • Provide training and guidance to QC personnel on data handling, transcription, trending, and reporting requirements.
  • Assist in data-related aspects of lab operations including supporting electronic systems (e.g., LIMS, CDS) and ensuring data backup and access protocols are followed.
  • Identify data quality issues and drive resolution through collaboration with relevant stakeholders.
  • Maintain awareness and compliance with FDA, EPA, and OSHA regulations and company safety standards.
  • Support sustainability and safety initiatives by reporting issues and halting unsafe practices when necessary.
  • Other tasks as assigned by Manager, QA and/or QA Team Lead
Requirements / Qualifications:
  • Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Life Sciences, or a related field.
  • Two to four years’ experience in a GMP-regulated laboratory setting with a focus on data transcription, analysis, or quality systems.
  • Proficient in Excel, statistical tools, and laboratory information management systems (LIMS).
  • Strong attention to detail, documentation, and data integrity principles.
  • Excellent organizational, communication, and problem-solving skills.
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