Job Description

Position: QA Validation Associate II

Location: Central Islip, New York, USA

Job Type: Full-Time | On-Site

Experience Required: 35 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

• Education: Bachelors degree in a relevant scientific discipline from an accredited institution.
• Experience: 35 years of pharmaceutical industry experience.
• Strong knowledge of GMP/Validation processes, manufacturing systems, and U.S. FDA regulatory requirements.
• Familiarity with pharmaceutical design, commissioning, and validation activities.
• Knowledge of solid or semi-solid dosage forms preferred.
• SAP system experience is a plus.

Physical Requirements

• Sitting and/or working at a computer or other screen for 75% or more of an 8-hour day.
• No remote work available; must be based in or near Central Islip, NY.

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