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Position Brand Description:

The Chemist – QC – IAPI (QC eSystems) provides electronic system technical and compliance support for Indianapolis API Operations QC.  The Chemist – QC – IAPI is responsible for design and execution validated computer systems, analytical method management, electronic notebook templates/scripting, investigations, and QC infrastructure connections. The Chemist – QC – IAPI will provide support for other support activities (i.e.: support, new equipment installation, data integrity, agency and internal inspections, system upgrades, change management, observation/deviation management, reviews, and related global initiatives).

Key Objectives/Deliverables:

Provide support for the implementation and maintenance of electronic notebooksSubject expert for laboratory computer system audit activities, validation and periodic reviewsInteracts effectively with business partners to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirementsUnderstands direction of technology and its impact on laboratory business processes, quality systems and the QC organizationImplements programs/processes which improve overall compliance and quality in the QC LaboratoriesTrain and Mentor analysts through formal process/programAssess, review and author change controls and deviations for eSystems and QC instrumentationUtilize technical skills to lead or perform in-depth investigations affecting data integrity.  Draws conclusions and performs root cause analysis investigations and recommends solution to prevent reoccurrenceSupport laboratory infrastructure and act as a liaison between QC and the IT organization (e.g., instrument interfacing, data archiving, technology infrastructure and data parsing)Evaluate new laboratory technologies for impact to other QC systems portfolio and provide direction in qualification of new equipment technologiesImprove laboratory quality systems; develop content, review and approve SOPs and training as necessaryInfluences business areas’ understanding of their own business processes, identifies new opportunities, challenges the status quo, and helps develop recommendation for using QC eSystems to improve business process productivity

Basic Requirements:

Bachelor’s Degree (4 year College) in a scientific field related to the lab (e.g., Chemistry, Microbiology or Biology) or 4-7 years of relevant experience in a GMP laboratory

Additional Preferences:

4+ Years of QC experience with a focus on electronic lab notebooks and instrument infrastructure.Deep understanding of laboratory quality systems and their dependencies (e.g., TrackWise, SmartLab, Darwin, Empower, NuGenesis and instrument controlling laboratory systems)Proficiency with computer systems and operating systemsDemonstrate strong oral, written communication and interpersonal interaction skills

Other Information:

Required to provide on-call support coverage for 24/7 operations

The job specification is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.  As always, you should consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

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