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
