Laboratory Technician II
Core
Conducting environmental, microbiological, and analytical testing in a regulated laboratory to ensure product quality and patient safety.
Role type
Mid-level hands-on laboratory technician (quality control)
Builds
Production quality data and test reports for medical device manufacturing
Domain
Medical devices / Pharmaceutical manufacturing
Required skills
HPLC/GC operation, FTIR, Dissolution Testing, pH Meter, Analytical/Micro Balance, Sample preparation, Equipment calibration and maintenance, Troubleshooting minor instrument issues, Method execution per validated procedures, GMP/GLP compliance, Data Integrity (ALCOA+), ISO 13485 knowledge, Laboratory safety protocols
Preferred skills
Experience in regulated industry (Medical Devices, Pharma, Biotech), Knowledge of FDA 21 CFR Part 820, Knowledge of ISO 13485
Technologies
HPLC, GC, FTIR, Dissolution testers, pH meters, Analytical balances
Responsibilities
Conduct Environmental Control testing (water/air/surface microbial/particulate), Perform Endotoxin and Bioburden testing, Execute Raw material, in-process, and finished product testing, Collect and analyze data to prepare laboratory reports, Maintain and review lab notebooks/logbooks/datasheets, Assist in solving quality-related problems, Document and report NCEs and out-of-specification results, Perform equipment cleaning, preventative maintenance, and qualifications, Support Internal/External Audits
Seniority
Mid-level, hands-on IC
