Laboratory Technician III

Job Description: ONSITE position - AH.
NO medical surveillance is required for this position.

Job Purpose
• Performs routine laboratory testing in accordance with FDA and other regulatory requirements, and internally established procedures and specifications.
• Assures the quality of medical device and combination products by supporting material and finished goods release testing.
• Perform sample analysis using liquid chromatography using established instrumentation settings, processing, and reporting methods.
• Collaborates with customers and co-workers to ensure testing is completed to meet established time lines.
• Supports equipment qualifications and method optimization and validation work.

Key Responsibilities
• Conducts sample, solution, and standard preparations for liquid chromatography team.
• Runs and interprets liquid chromatography (HPLC/UPLC) data to quantify total drug content and impurities/degradants.
• Maintains documentation/laboratory notebook to support analytical testing.
• Utilizes validated excel spreadsheets to calculate results.

Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Minimum Qualifications:
• Industry experience in chemistry laboratory setting with basic skills such as pipetting, good weighing practices,
utilization of class A glassware, solution and standard preparations, and handling of chemicals.
• Experience operating liquid or gas chromatography equipment.
• Working knowledge of cGMP and GDP requirements and principles.

Preferred:
• 4-year degree in science related field
• Industry experience (1+ yrs.) operating Liquid Chromatography equipment such as IC, HPLC, UPLC, or GPC
OT: Eligible for 1.40 OT Mark-Up: Yes