About this role
Conduct biochemical analyses under supervision, including cell counts, flow cytometry, ELISA, and PCR analysis, plus basic compendial testing (pH, conductivity, appearance) in line with USP, JP, and EP standards. Assist with documentation and review of results to ensure alignment with current Good Manufacturing Practices (cGMP). Provide general lab support: housekeeping, equipment maintenance, inventory management, ordering of lab supplies, glassware handling, autoclaving, and related tasks. Support sample logistics, including retention sample storage, external lab testing, QC document control, and shipment of QC samples. Prepare and maintain standards and reagents as required by GMP documents. Ensure data integrity and proper documentation practices. Contribute to operational efficiency and continuous improvement initiatives. Assist with troubleshooting of analytical methods and equipment; participate in equipment qualification, maintenance, and troubleshooting under supervision. Assist with OOS (out-of-spec) investigations and deviation investigations; help draft investigation reports. Learn and follow data integrity requirements and GMP/compliant data practices. Perform other duties as assigned by your Supervisor/Manager. Requirements Bachelor’s degree in a relevant science field or equivalent experience. Some knowledge of CSV (Comma-Separated Values) and basic data handling in spreadsheets; familiarity with data recording and traceability in a regulated environment is a plus. Interest in laboratory QC processes, attention to detail, and a proactive approach to learning. Strong teamwork, communication, and problem-solving skills. Basic understanding of GMP concepts and willingness to adhere to strict documentation standards. Ability to follow SOPs and work under supervision in a fast-paced environment. Nice to have: Exposure to flow cytometry, ELISA, PCR, or other biochemical assays. Prior internship or lab assistant experience in a QC or regulated lab. Familiarity with laboratory software, LIMS, or electronic batch records (EBR).
