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QC Analyst I

  • Anywhere

Company :
United Therapeutics

Location :
Silver Spring, Maryland

Expiry Date :
Fri, 26 Mar 2021 23:59:59 GMT

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Description :
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 youll contribute To ensure the timely and accurate testing of products while maintaining and ensuring quality and compliance so as to meet the demands of manufacturing. – Analyze samples in support of instrument qualification; method verification and validation; process validation; in-process testing requirements; Product Development (PD), stability testing; and finished/release product testing. – Prepare solvent mixture, buffers and reagents as needed. – Assist in the installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ) of new laboratory equipment as needed. – Review standard operation procedures (SOPs) for equipment operation, methods and general laboratory procedures as needed. – Follow company SOPs and cGMP in the performance of all responsibilities. – Process or analyze bioanalytical and analytical data. – Review bioanalytical and analytical data or test results and compare to test specifications. – Troubleshoot with the team lead and/or manager when problems arise to resolve issues. – Perform instrument maintenance and calibration verification/standardization as required. – Perform duties in support of raw materials, stability pulls, laboratory audits, laboratory cleanliness and other duties as necessary. For this role you will need Minimum Qualifications – Bachelors degree in biochemistry, chemistry, or other scientific discipline with equivalent experience/training – 2+ years of experience in laboratory environment with at least 1 year in a QC environment – Experience in cGMP documentation in QC environment – Basic analytical techniques such as balance use and pH meter use – Biologic experience in spectrophotometer testing, micropipetting – Proficient in Word, Outlook and Excel – Must be nimble in order to meet our timelines and goals efficiently and effectively – Must be accountable to be in compliance while working in a GMP environment – Must be collaborative, and able to work as part of a team and also independently with minimum supervision Preferred Qualifications – Instrumentation experience in HPLC, UPLC – ELISA experience – Experience with chromatography software preferably Empower 3 experience – Experience in LIMS Labware – Experience with being trained in current good manufacturing practices (cGMP) is preferred – Experience with USP testing requirements – Experience with stability testing programs Life as a Unitherian At United Therapeutics, youll 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