Category: Scientific & Clinical
Title: Microbiologist – I
Location: Wilson, NC
Start date: ASAP
- Supports continuous improvement and supports sustainability of implemented changes. Identifies and implements continuous improvement changes within the laboratory.
- Ensures work is completed right first time. Participates in root cause and corrective action identification and documents investigations.
- Participates and leads, when required, Tier I and Tier II activities.
- Demonstrates working knowledge of product performance and testing methodology.
- Provides an environment conducive with the 12 Inclusive Behaviors, actively promotes an inclusive culture and leads by example.
- Responds to and remediates audit observations.
- Demonstrates working knowledge of equipment and ensures proper usage of equipment occurs.
- Participates in coordination of testing activities within work team.
- Tests and interprets results for any of the following: raw materials, active pharmaceutical ingredients, water, microbial limit testing, finished pharmaceutical products, and stability samples.
- Maintains compliance by following corporate policies/guidelines and local SOP’s.
- Interprets compendial and internal monographs, NDAs, and Quality Standards.
- Provides analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers, and API Stability Packaging Description (ASPD).
- Assures laboratory compliance by adhering to cGMP, CFR, and other agency regulations.
- Revises laboratory procedures as required.
- Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents in the laboratory.
- Maintains 5S organization throughout the laboratory and identifies improvement opportunities.
- Participates in project activities designed to improve the business operation of the laboratory, the compliance posture of the laboratory, the skills and capabilities of the laboratory, etc.
- Performs Purified/Potable Water sampling and testing.
- Performs Compressed Air Utility sampling and testing.
- Performs Environmental Monitoring sampling and testing
- Supports GLIMS as necessary.
- Performs Microbial Enumeration Testing per USP <61> & <62>.
- Performs any other work as assigned by Manager.
- B.A./B.S. degree (preferably in Science or Engineering)
- Knowledge of continuous improvement principle
- Root cause analysis
- Background in technical writing
- Experience applying 5S concepts
- Experience operating routine laboratory equipment including but not limited to: pH, TOC/CONDUCTIVITY, Biological Safety Cabinets etc
- Experience with SAP/Trackwise
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.