Quality Assurance Associate III

*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 Producted 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.