BioSpace · 3 days ago

QA Representative Batch Disposition

Concord, NC

Full-time

Onsite

Entry, Mid Level

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Comp. & Benefits

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Responsibilities

Support the site in the development and execution of the site readiness plan with focus on supporting development of the site e-release process and startup of new systems

Performs final batch disposition of semi-finished and/or finished drug product and combination product batches, to ensure high-quality medicine (GMP Compliance) is released to market in a timely manner

Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: Deviations, procedures, protocols, specifications, and change controls)

Qualification

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QAPharmaceutical IndustryMedical Device IndustryBatch DispositionSAPMESTrackwiseRoot Cause AnalysisRegulatory Inspection ReadinessEventChange ManagementComputer SystemsManufacturing Sites CoordinationProblem-SolvingCommunication

Required

Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent experience

Experience working in the pharmaceutical or medical device industry in QA roles

Previous batch disposition experience

Preferred

Proficiency with SAP, MES, and Trackwise

Root cause analysis/troubleshooting skills

Previous regulatory inspection readiness and inspection execution experience

Previous experience with Event and Change Management process

Previous experience with device and parenteral product materials

Previous experience with applicable computer systems

Ability to work 8-hour days – Monday through Friday Day Shift (not eligible for remote work)

Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites

Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or R1-R4.