Laboratory Technician 3rd Shift

Summary

The Laboratory Technician is a critical member of the Quality Control team, ensuring the safety, efficacy, and compliance of primary packaging components for the healthcare industry. You will be responsible for the end-to-end analytical testing of raw materials and finished products, operating within a high-standard ISO 7 cleanroom environment and adhering to global cGMP.

Essential Functions and Responsibilities

• Conducts daily microbiological and particulate monitoring of site water systems and cleanroom environments (ISO 7 or better) to ensure compliance with pharmacopeial standards.

• Identifies and reports environmental trends to prevent microbial excursions before they impact production.

• Performs chemical and physical testing on raw materials and batches, including FTIR spectroscopy, moisture analysis, and volatile sulfides.

• Executes specialized tests such as coring/fragmentation, penetration force, and seal integrity (CCIT).

• Covers bioburden, endotoxin (LAL), and sub-visible particulate testing using automated equipment.

• Ensures all laboratory records are Attributable, Legible, Contemporaneous, Original, and Accurate.

• Utilizes SAP and LIMS (Laboratory Information Management Systems) for batch release and real-time data entry.

• Applies statistical tools (e.g., Minitab) for Root Cause Analysis (RCA) and Out of Specification (OOS) investigations.

• Participates in the qualification (IQ/OQ/PQ) of new laboratory instrumentation.

• Performs routine calibration and troubleshooting of sensitive analytical equipment.

Requirements

• Education: Minimum High School Diploma/GED; Associate’s or Bachelor’s degree in Microbiology, Biology, or Chemistry is highly preferred.

• Experience: 1–3 years in a regulated laboratory environment (Pharma, Biotech, or Medical Device).

• Technical Skills: Proficiency in MS Office and SAP. Familiarity with Minitab or similar statistical software. Hands-on experience with cleanroom gowning and aseptic techniques.

• Soft Skills: Strong team orientation, emotional intelligence, and a high degree of ownership over quality outcomes.