Quality Assurance Associate III

4 weeks ago

Waltham, United States Katalyst Healthcares and Life Sciences Full time

Responsibilities: Person in Plant for Manufacturing runs. Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations. 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 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 ssist with internal and external audits. Lead compiling data analysis and metrics for QMR, KPIs, and other reportable forums may be requested. ssume additional responsibilities as assigned. Requirements: Bachelor's and/or 8+ years of relevant experience Minimum 5 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. Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project. Excellent communications skills both written and verbal. Effective time management and organizational skills. Strong attention to details and ability to lead others in a team setting. bility to gown and enter clean rooms Perform review of Batch records and associated documents in support of the release of a product. Review of Analytical data Perform QA presence on the floor/person in the plant Ensure that documentation and operations meet established requirements of cGMPs, Internal SOPs, and company policies. Draft and revise procedures as required. Performs work that requires decision-making and the consistent exercise of independent judgment and discretion

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