USA-Quality Assurance Associate III (Scientific) in

  • Title: USA-Quality Assurance Associate III (Scientific)
  • Code: RCI-9232
  • RequirementID: 53620
  • Location:
  • Posted Date: 11/29/2024
  • Duration: 11 Months
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  Job Description

*The position will onboard in January Hybrid Role The Requirements for this position is: • Bachelor’s and/or 8+ years of relevant experience • Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences) • Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment. • Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants. • Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines. • Preferred experience with outsourced manufacturing and testing operations • Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project. This role will be: • Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials • Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations. • Ensure that all requirements, as stipulated in the appropriate QTA, have been met. • Issue/Review documentation, i.e. Deviations, CAPAs, OOS (out of spec) etc., as they occur. • Write and revise SOP, forms, WI, and any other document types • Assist with internal and external audits. • Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested. • Assume additional responsibilities as assigned.

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