QA Validation Technician I - Tampa, FL

Job Description

Job Description

Description:

Performs practical laboratory work including method development, method validation, and troubleshooting. Assumes responsibility for the QC portion of projects. Conducts required testing on raw materials, intermediates, and finished products. Supports QC chemists with method technology transfer and project preparation to ensure timely and smooth project execution.

• Transcribes 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.

• Reviews, analyzes, and trends laboratory data from environmental, raw material, in-process, and final product testing to ensure conformance with specifications and regulatory requirements.

• Ensures accurate, timely, and compliant documentation of all data in accordance with cGMP and Standard Operating Procedures (SOPs).

• Maintains databases and electronic records for laboratory data, ensuring data integrity and regulatory compliance.

• Authors, revises, and reviews SOPs, data review templates, and protocols to support consistent data handling practices.

• Collaborates with QC laboratory staff to investigate data deviations and supports root cause analysis and CAPA development.

• Provides data reports, summaries, and metrics to support production, investigations, and continuous improvement initiatives.

• Reviews GDP and data integrity to ensure review and approval of all GxP data generated for projects are managed and evaluated according to relevant protocols, SOPs, and regulatory requirements.

• Supports method and equipment validation through data compilation and statistical evaluation.

• Participates in internal, customer, and regulatory audits by preparing data packages and responding to data-related inquiries.

• Provides training and guidance to QC personnel on data handling, transcription, trending, and reporting requirements.

• Assists in data-related aspects of lab operations including support for electronic systems (e.g., LIMS, CDS) and adherence to data backup and access protocols.

• Identifies data quality issues and drives resolution through collaboration with relevant stakeholders.

• Maintains awareness of and compliance with FDA, EPA, and OSHA regulations and company safety standards.

• Supports sustainability and safety initiatives by reporting issues and stopping unsafe practices when necessary.

• Performs other tasks as assigned by the Manager, QA, and/or QA Team Lead.

• Holds a Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Life Sciences, or a related field.

• Possesses two to four years of 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).

• Demonstrates strong attention to detail, documentation, and adherence to data integrity principles.

• Exhibits excellent organizational, communication, and problem-solving skills.