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

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