QC Analyst II

United Therapeutics Corporation
Silver Spring, MD
Nov 09, 2018
Nov 23, 2018
Full Time
The Job Details are as follows:OverviewWe need your cGMP documentation in a QC environment background to join our team as a Quality Control ("QC") Analyst II. In this role, you will 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 R&D.Key Accountabilities / ResponsibilitiesAnalyze samples in support of: instrument qualification; method verification and validation; the raw material testing program; process validation; in-process testing requirements; R&D, stability testing; API testing and finished product testingPrepare solvent mixture, buffers and reagents as needed for testingAssist in the installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ) of new laboratory equipment as neededWrite and review standard operating procedures (SOPs) for equipment operation, methods and general laboratory procedures as neededFollow company SOPs and cGMP in the performance of all responsibilitiesDo method development and method validation for specified projectsProcess and analyze microbial, bioanalytical and analytical dataReview bioanalytical and analytical data and test results and compare to test specifications. Prepare analytical lab reportsTroubleshoot instrument problems and work with the lab supervisor/manager and equipment manufacturer's technical services to resolve issuesPerform instrument maintenance and calibration verification/standardization as requiredSample raw materials as neededInteract professionally with internal and external vendors to support the QC missionPerform other duties as necessaryMinimum RequirementsBachelor's degree in Biochemistry, Chemistry, or other scientific discipline3+ years of experience in laboratory environment3+ years of experience in cGMP documentation in QC environmentInstrumentation experience and expertise on laboratory equipment such as Capillary Electrophoresis, UPLC, HPLC, Spectroscopy, (UV and IR), wet chemistry and USP testing, as well as other investigative techniquesExperience in bioanalytical and analytical method development/validation and lab method transfer protocols are requiredAble to handle, pick up and move laboratory materials, reagents and supplies, some up to 10Lbs, as well as sample raw material in a warehouse settingProficient in Word and Excel and chromatography (Empower & 32-Karat) application programsPreferred Knowledge, Skills, and AbilitiesMaster's degree in Biochemistry, Chemistry, or other scientific discipline4+ years of experience in a cGMP pharmaceutical laboratory in large and small molecule drug analysis preferredExperience in FDA and USP testing requirements is a plus.Experience in stability testing programs is a plusExperience with chromatography client server systems is a plusUnited Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

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