QC - Microbiologist II

3 days left

United Therapeutics
Jacksonville, Florida, US
Apr 28, 2021
May 15, 2021
Employment Type
Full time
Salary Type
The Job Details are as follows:
What we do
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.
We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.
How you'll contribute
To ensure the timely and accurate testing of materials and product while maintaining and ensuring quality and compliance so as to meet the demands of production and other departments.
- Support of all manufacturing operations; including but not limited to process validation, environmental monitoring, and utility systems sampling and testing.
- Perform all in-house microbiological assays.
- Perform all environmental, water, and other utility sampling procedures.
- Coordinate with Manager and other staff members in organizing workload.
- In a timely fashion, review and release of microbial test results as to ensure compliance with the standard operating procedure (SOPs) and ensure reported data is accurate.
- In a timely fashion, prepare analytical lab reports or summaries as required.
- Write, revise, and review SOPs for compliance with respective compendia, equipment operation, methods and general laboratory procedures as needed.
- Troubleshoot instrument problems and work with the lab manager and equipment manufacturer's technical services to resolve issues in a timely fashion. Perform instrument maintenance and calibration verification/standardization as required following company SOPs.
- Initiate and complete out of specifications (OOS), deviations as needed
- Maintain and support RAM, ELPRO databases
- Sample raw materials as needed
- Schedule, and coordinate shipping of samples for required testing to contract laboratories.
- Train other departments employees in departmental operations and SOPs as required.
- If required, schedule and coordinate annual preventive maintenance and/or calibration of the various Microbiological instruments as to ensure compliance with the calibration program.
For this role you will need
Minimum Qualifications
- Bachelor Degree in Microbiology or Biology or other scientific discipline with equivalent experience/training.
- Training in cGMP practices.
- A minimum of 2 years experience in a cGMP pharmaceutical/biotechnology microbiology laboratory.
- Working knowledge and understanding of cGMPs, USP, and other regulatory requirements.
- Gowning
- Aseptic technique
- Utility monitoring including but not limited to water sampling, viable and non-viable particulate monitoring
- Gram staining
Preferred Qualifications
Demonstrated proficiency in the following techniques:
- Sub-culturing of microbial isolates
- Bacterial endotoxin testing
- Bioburden testing by membrane filtration
Life as a Unitherian
At United Therapeutics, you'll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.