Scientist I

at Fagron Sterile Services in Wichita, Kansas, United States

Job Description

Responsible for performing routine testing of in-process and finished product samples. Summarizes environmental monitoring and product test results. Provides project support to Scientist, Lead Scientist, and Senior Scientist, as needed. Performs AQL visual inspection.

Key Responsibilities

• Performs routine testing of in-process and finished products and provides support for protocols for product validation and environmental monitoring.
• Performs AQL visual inspection.
• Performs microbial enumeration and gram staining, and growth promotion testing, as needed.
• Performs duties related to sample receipt, shipping to contract laboratories, and disposal of sample retains
• Must be able to understand and follow good documentation practices
• Assists Scientist / Lead Scientist / Senior Scientist with test method validations and special projects related to environmental monitoring or sterility testing.
• Monitors and tracks microbiological test results.
• Conducts routine entries for summaries of test results for trend analysis.
• Promptly reports data discrepancies and out of limits conditions to supervision.
• Provides edits for standard operating procedures for microbiology test procedures as well as other Quality Control documentation.
• Carries out documentation, investigation, author incident reports, and conducts corrective actions under management supervision.
• Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the department.
• Maintains knowledge of cGMP and is required to keep current on training and training assignments.
• Follow safety requirements, maintain good housekeeping of laboratory areas, orders laboratory supplies to maintain inventory and prepares test media and reagents as assigned.
• Participates in any and all reasonable work activities as assigned by management.