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Quality Assurance Associate II (Scientific)

Job Description

Responsibilities:

Reviews and approves master production records for the timely initiation of GMP manufacturing activities.
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
SME for Quality in vendor meetings for raw materials, excipients, cell banks and plasmids
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 etc., as they occur.
Write and revise SOP, forms, WI, and any other document types
Assist with internal and external audits.
Lead compiling data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
Assume additional responsibilities as assigned.

Requirements:

Bachelor's degree and/or 10+ years of relevant experience; Masters preferred
Minimum 8 years of experience in Quality Assurance
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.

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