Quality Assurance Associate Iii

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
• 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 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.
• Ability 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