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Compliance/ Deviation Investigator

Company: Trinity Consultants - Advent Engineering Life Scie
Location: Walton
Posted on: January 16, 2022

Job Description:

Compliance/Deviation Investigator Essential Duties and Responsibilities include, but are not limited to the following:--- Writing, leading, and managing detailed investigations.--- Performance of Fact Finding, Assessment and Determination of Root Cause (RCA), generation of CAPAs, and coordination and management of cross-functional teams.------- A high level of aptitude for cGMP biopharmaceutical manufacturing processes (upstream/downstream), including process knowledge of UF/DF Systems, Chromatography, Bioreactors, Seed Train, Disposable Technologies (SUMs, SUBs), Clean-in-Place (CIP), and Steam-in-Place (SIP).--- A high level of aptitude for metrology, maintenance systems, preventative maintenance, HVAC, WFI, Clean Steam (CS), Compressed Air Pharmaceutical.--- Responsible for generating and tracking performance metrics.--- Maintains knowledge of current good manufacturing practices cGXPs.--Knowledge, skills, and abilities:--- Knowledge of drug product manufacturing from formulation through the final package.--- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.--- Proficient in Excel, PowerPoint, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments.--- Strong interpersonal, written and oral communication skills.--- Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.--- Shows resiliency and flexibility in the face of challenges and adversarial situations and tight deadlines.--- Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective.Education and Experience:--- A minimum of BS/BA in scientific or engineering discipline with 3+ years of related experience in investigations and cGMP manufacturing operations (clinical and/or commercial drug products).--------

Keywords: Trinity Consultants - Advent Engineering Life Scie, Scranton , Compliance/ Deviation Investigator, Other , Walton, Pennsylvania

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