QC Analyst III

Company: United Therapeutics Corporation
Location: Silver Spring
Posted on: June 1, 2021

Job 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 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 manufacturing.

• Analyze samples in support of: instrument qualifications; 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.
• Write and review standard operating procedures (SOPs) for equipment operation, methods and general laboratory procedures as needed.
• Follow company SOPs and cGMP in the performance of all responsibilities.
• Assist with method development and method validation for specified projects.
• Process and analyze bioanalytical data.
• Review bioanalytical data and test results and compare to test specifications. Prepare lab reports.
• Troubleshoot problems that arise and come to a resolution that can be proposed to the laboratory team lead and/or management. Analyst must be able to work with equipment manufacturer's technical services to resolve issues.
• Perform efficient and timely OOS investigations and deviations when required.
• Perform instrument maintenance and calibration verification/standardization as required.
• Assist with report writing/review for annual/biannual commitments
• 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

• Bachelor's degree in biochemistry, chemistry or other scientific discipline with equivalent experience/training.
• 6+ years of experience in laboratory environment with a least 4 of those years in a QC environment
• Experience in bioanalytical and analytical method development/validation
• Proficient in cGMP documentation
• Good computer application use and knowledge
• Instrument experience in Capillary Electrophoresis, HPLC, UPLC, ELISA testing

• Biologic experience in spectrophotometer testing, micropipetting

• Proficient in Word and Excel and chromatography application programs
• Ability to effectively and efficiently problem solve - necessary for troubleshooting
• Ability to prioritize day to day workload
• Must be a critical thinker
• Must be a proactive team member and able to work as part of a team and also independently with minimum supervision
• Good verbal and written communication skills
• Able to handle, pick up and move laboratory materials, reagents and supplies
• Chemical disposal procedures and laboratory safety precautions

Preferred Qualifications

• Master's degree in biochemistry, chemistry or other scientific discipline with equivalent experience/training.
• Instrumentation experience in different types of detection techniques in capillary electrophoresis such as UV, PDA and Fluorescence
• Compendial testing
• LIMS - Data Management System
• Trackwise - deviation/change control
• MasterControl - training database
• 32 Karat Software for CE
• Experience with FDA and USP testing requirements
• Experience in stability testing programs

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

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