Address
Form of work Role: Microbiologist
Location: East Syracuse, NY 13057
Duration: 12 Months
Shift: 06:00 AM 03:00 PM
Position Summary:
Qualifications:
Duties/Responsibilities:
Responsibilities:
Location: East Syracuse, NY 13057
Duration: 12 Months
Shift: 06:00 AM 03:00 PM
Position Summary:
- The AQO group supports the onsite small scale commercial manufacturing facility. This position conducts environmental and utility monitoring in compliance with procedures, protocols, and regulatory requirements.
- This position performs lab analysis of environmental samples according to defined procedures.
Qualifications:
- Preferred knowledge of aseptic technique, environmental monitoring and Microbiological Quality control testing and procedures. Ability to complete sampling or work assignments in a timely and compliant manner with minimal supervision.
- Perform limited interpretation of data. Demonstrate ability to handle multiple assignments simultaneously and complete assignments in a timely and compliant manner with minimal supervision. Must have effective verbal and written communication skills.
Duties/Responsibilities:
- Conduct routine Microbiological sampling and analyses of environmental monitoring and a variety of clean utility samples using aseptic technique and in compliance with established procedures and regulatory requirements.
- Prepare and review of test results and documentation associated with daily operations of the AQO Sample Group, which performs a wide variety of regulatory, microbiological analyses to evaluate environmental samples using aseptic technique and in compliance with established procedures and regulatory requirements.
- Conduct and review investigations of deviations and environmental monitoring excursion results as required.
- Update and write new procedures, protocols, and reports as required.
- Conduct environmental monitoring qualification studies according to scientific protocol.
- Maintain accurate records of work performed and document results according to good documentation practices and established procedures as well as perform data entry into LIMS.
- Promotes quality, safety, and health by ensuring clean work area and adherence to procedures and safety culture.
- Support the implementation of new equipment/instrumentation by performing required testing in support of validations and qualifications.
Responsibilities:
- The Aseptic Quality Operations (AQO) group supports the onsite small scale CDMO (Contract Development Manufacturing Organization) facility.
- The AQO Technician conducts routine microbiological sampling of classified and non-classified manufacturing areas and utilities in compliance with methods, procedures, protocols and regulatory requirements.
- The AQO technician utilizes aseptic technique while performing sampling, conducts lab processing and analysis of environmental samples, prepares and reviews investigations for environmental deviations, and analyzes, evaluates and interprets data to assist in resolving issues.
