QA Validation Associate II

Position : QA Validation Associate II

Location : Central Islip, New York, USA

Job Type : Full-Time | On-Site

Experience Required : 3–5 years

Shift : Monday to Friday, 8 : 30 AM – 5 : 00 PM

Position Overview

We are seeking a highly detail-oriented QA Validation Associate II to join our Quality Assurance team. The successful candidate will support GMP documentation review, ensure compliance with regulatory and industry standards, and assist with continuous quality improvements for manufacturing and release processes of drug substances and products.

Key Responsibilities

• Review and approve documentation related to commercial, development, and engineering manufacturing activities in line with Good Documentation Practices (GDP).
• Independently execute batch record reviews for completeness, accuracy, and cGMP compliance.
• Support evaluation and lot disposition of intermediates, bulk substances, and finished drug products.
• Review test methods, validation protocols, and reports for accuracy and compliance.
• Compile and report performance metrics for Batch Review and Release.
• Identify process improvement opportunities to meet QA batch disposition timelines.
• Act as QA reviewer for deviations, investigations, and CAPAs.
• Ensure compliance with company policies, cGMP, and EHS standards.
• Collaborate across functions including Manufacturing, Supply Chain, and Technical Support to ensure smooth operations.
• Participate in internal quality and process improvement initiatives.

Qualifications

Physical Requirements