Performs individual hands-on work in the sterility testing program. The Microbiologist provides scientific guidance and interpretation of environmental monitoring and microbiology results to production management.
Responsibilities may include:
- Compiles and interprets results of environmental monitoring tests and sterility results;
- Conducts investigations of all non-conforming results;
- Identifies environmental microbial isolates by classical techniques and automated identification methods to meet the requirements of the microbial environmental monitoring program;
- Evaluates cleaning effectiveness on a routine basis to determine robustness of disinfection.
- Develops and/or performs water sampling, including DI water, WFI and steam per the program (when needed);
- Performs and/or oversees surface and air sampling of the facility areas and equipment per the program;
- Performs and/or oversees environmental monitoring of all facility areas in compliance with gowning requirements;
- Validates methods and perform sterility (USP ), Scan RDI and endotoxin (USP ) testing for finished goods;
- Performs growth promotion testing of media;
- Prepares reports and communicate results for the environmental program per facility standards;
- Trains and maintains current training status on required equipment and procedures;
- Perform other duties as assigned.
- Legally authorized to work in the job posting country
- Must have a B.S. degree in related field (preferably Microbiology)
- 4 + years of experience in Microbiology, preferably in pharmaceutical manufacturing
- Previous training and experience in environmental monitoring, sampling and laboratory microbiology (USP 71, Growth Promotion Testing, Methods Validation)
- In-depth knowledge of environmental monitoring, sampling and the microbial testing and microbial method validation requirements. Experience with Rapid Microbiological testing methods a plus.
- Thorough understanding of 21CFR Part 211 cGMP requirements for sterile drug products with emphasis on 2004 Guidance for Sterile Drug Products produced by Aseptic Processing.
To be considered:
In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.
Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.
It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.