Quality Assurance Technician

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.