Environmental Monitoring Technician - SOFIE : Job Details

Location: Totowa, New Jersey

Department: Radiopharmaceutical Contract Manufacturing

Overview: The Microbiology - Environmental Monitoring Technician supports microbiology and manufacturing activities at the NJ5 site by (1) performing Environmental Monitoring (EM) as per sampling schedules (2) detecting, quantifying, identifying, and aiding in investigations for possible contaminants that may impact the quality of product during different stages of the manufacturing process.

Essential Duties and Responsibilities:

• Provide Environmental Monitoring (EM) support to GMP manufacturing areas. Perform EM testing for Active and Passive (settle plate) monitoring of Viable Particulates (Viable Air and Viable Surface RODAC), and Non-Viable Total Particulates.
• Follow EM sampling schedules in accordance with procedures, performing sampling of rooms and equipment.
• Perform EM sample management from incubation through isolate ID and completion of EM documentation.
• Work independently and with cross-functional groups to implement the environmental monitoring program to ensure the compliance of facility.
• Aid in EM investigations to determine root cause and provide expert guidance on required corrective actions for EM excursions.
• Assist in Growth Promotion conduction as necessary for EM related media.
• Support Microbiology team in the conduction of trending EM and relevant Out of Specification (OOS) data against acceptance specifications.
• Notify Microbiology/ EM Supervisor, Quality Control Manager, and Facility Manager of any identification of all microbial contamination.
• Support finished product release by checking results for sterility, endotoxin, and particulate matter testing (as required).
• Maintain aseptic environment for Microbiology and Stability laboratories, including regular maintenance of all equipment pertaining to EM.
• Disposal of hazardous waste and non-hazardous waste from Microbiology / Stability laboratories.
• Interact with management to suggest approaches to increase efficiency that will allow for better operations in the laboratory.
• Follow compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 211 and 212 requirements.
• Other responsibilities required.

Qualifications:

• Bachelor's Degree in a Life Science discipline (B.Sc. in biology/ microbiology or related field preferred) and 0-3 years in a cGMP laboratory/ production environment including performing environmental monitoring.
• Knowledge of and previous experience performing Environmental Monitoring is preferred.
• Knowledge of USP, FDA, and cGMP regulations preferred.
• Knowledge of how and ability to write, review, and revise SOPs required.
• Ability to read, analyze, and interpret governmental regulations, professional journals, or technical procedures required.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.
• Ability to define and solve problems, collect data, establish facts, and draw valid conclusions required.
• Proficiency in MS Office applications required.
• Strong interpersonal communication skills for interacting with site personnel in both quality and manufacturing.