Execute practical laboratory work, including method development, method validation, and troubleshooting.
Perform quality control testing on raw materials, intermediates, and finished products to ensure compliance with specifications.
Support method technology transfer and project execution to ensure timely, smooth progression of QC-related deliverables.
Accurately transcribe laboratory data from worksheets, logbooks, and instrument outputs into electronic systems and official records in accordance with cGMP and data integrity requirements.
Analyze, trend, and review laboratory data for environmental, raw material, in-process, and final product testing.
Maintain and manage databases and electronic records, ensuring accuracy, traceability, and regulatory compliance.
Draft, revise, and review SOPs, protocols, and data review templates to support standardized data practices.
Collaborate with QC teams to investigate data deviations and support root cause analysis and CAPA implementation.
Generate data reports, summaries, and metrics for production support, audits, and continuous improvement initiatives.
Review GxP data for compliance with Good Documentation Practices (GDP) and regulatory protocols.
Support method and equipment validation through data compilation, statistical analysis, and reporting.
Prepare data packages for internal, client, and regulatory audits; respond to data-related inquiries.
Provide training and mentorship to QC personnel on data handling, transcription, and reporting procedures.
Assist in maintaining electronic lab systems (e.g., LIMS, CDS), ensuring data backup and access protocols are followed.
Identify data quality issues and facilitate timely resolutions through collaboration with stakeholders.
Maintain compliance with FDA, EPA, OSHA, and company-specific safety and regulatory guidelines.
Support company sustainability and safety programs by reporting hazards and halting unsafe practices when needed.
Perform additional tasks as assigned by QA Manager and/or QA Team Lead.
Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Life Sciences, or a related scientific discipline.
2–4 years of experience in a cGMP-regulated laboratory environment, particularly in data transcription, analysis, or quality systems.
Proficiency in Microsoft Excel, statistical tools, and Laboratory Information Management Systems (LIMS).
Strong knowledge of cGMP, GDP, and data integrity principles.
Excellent attention to detail, organizational, and documentation skills.