Quality Assurance Associate III

1 Year Contract Hybrid Shift: Mon-Fri 8am-5pm or 9am-6pm Job Responsibilities • 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. • 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. • Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested. Education & Qualifications • 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. Must Have Experience: • Bachelor’s and/or 8 years of relevant experience • Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences) – must be specific to pharm industry • PHD may be considered overqualified Nice to Have Experience: • Investigation or product complaint experience