QC Analyst III
Company: United Therapeutics Corporation
Location: Silver Spring
Posted on: June 1, 2021
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
- Follow company SOPs and cGMP in the performance of all
- Assist with method development and method validation for
- 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
- Perform instrument maintenance and calibration
verification/standardization as required.
- Assist with report writing/review for annual/biannual
- Perform duties in support of raw materials, stability pulls,
laboratory audits, laboratory cleanliness and other duties as
For this role you will need
- 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
- 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
Keywords: United Therapeutics Corporation, Silver Spring , QC Analyst III, Other , Silver Spring, Maryland
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