GMP Quality Assurance Associate II (m015)

Job description

Lenox Executive Search is seeking an experienced GMP Quality Assurance Associate II to fill a 11+ month contractual, Hybrid position with a leading global pharmaceutical company. In this role you will review and approve master production records for the timely initiation of GMP manufacturing activities.

RESPONSIBILITIES of the GMP Quality Assurance Associate II:
•      Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substances, 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 for the GMP Quality Assurance Associate II:
•      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.