Summary of Responsibilities:

The QC Microbiologist I, Environmental Monitoring will learn, understand, and perform routine entry level sampling of cleanrooms and utilities according to written procedures under cGMP conditions; as well as tasks involved with clerical and logistical laboratory tasks.

Specific Responsibilities:

• Environmental Monitoring of ISO-5, ISO-7, and ISO-8 cleanrooms (contacts, viable airs, and total particulate sampling) in accordance with approved methods
• Perform gowning qualification of personnel
• Utility sampling of RODI/WFI water systems (collect Bioburden and Endotoxin samples for testing) in accordance with approved methods
• Train personnel on environmental monitoring
• Prepare and host environmental monitoring meetings
• Document all results in accordance with SOP
• Report procedural deviations and nonconformances to management
• Write and review investigations (Environment Control Notification, NCR, OOS, Planned Deviation)
• Preparing samples for outside vendor testing
• Receiving and approval stickering of incoming microbiological media and reagents
• Perform data entry, filing, and scanning of completed documents
• Sterilization and cleaning of laboratory equipment
• Sampling of incoming raw materials as needed (i.e. Sodium Hyaluronic Acid Powder)
• Monitor room pressure readings in cleanrooms daily.
• Participate in other projects as assigned
• Job Complexity
• The position normally works on assignments routine in nature and receives detailed instructions on all work.
• Responsible for supporting QC Laboratory working environment

Supervisory Responsibilities:

None

Experience, Knowledge, and Skills Required:

• Associates or Bachelors Degree preferred or equivalent experience.
• 1 - 2 years previous experience in a GMP laboratory desired; internship experience considered
• ISO-5 (also known as Grade A or Class 100) Gowning experience
• Ability to work flexible hours to complete work activities
• Self-motivated with good time management and organizational skills
• Good communication and writing skills