Quality Assurance Associate II

Job Description: • Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities. • Perform QA review of Executed Batch Records. • Perform QA review of Quality Records, i.e. Deviations, CAPAs, OOS etc., as they occur. • Perform QA review and approval on SOPs, forms, WI, and other document types. • Provide SAP support for GMID and BOM approval. • Provide Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials. • Ensure all requirements, stipulated in the CMO Quality Agreements, are being met. • Review and Approve Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments, if needed. • Participate in Quality Risk Assessments • Assist with internal and external audits. • Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested. • Assume additional responsibilities as assigned.

Competencies/ Requirements for position Qualifications/ Education & work experience • Bachelor's and/or 8+ years of relevant experience • Minimum 5 years of experience in Quality • 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.