Quality Assurance Associate

About the role

Allied Reliability is seeking a Quality Assurance Associate to support Quality Production Operations in Hamilton, NY. This position plays a critical role in ensuring products are manufactured in compliance with established procedures, quality standards, and regulatory requirements. The successful candidate will work closely with Production and Quality Management teams to maintain product quality, accuracy of documentation, and compliance throughout the manufacturing process.

Key Responsibilities

• Conduct routine audits of filling and packaging operations to verify compliance with established procedures and quality standards.
• Perform environmental monitoring within aseptically classified production areas.
• Analyze and report environmental monitoring (EM) results, including plates and media.
• Complete data entry and prepare quality-related reports and documentation.
• Generate, review, control, and issue production batch record documentation.
• Inspect, analyze, and release materials and components used in production.
• Monitor charts, gauges, and equipment documentation to ensure compliance with specifications.

Qualifications

• Knowledge of GMP (Good Manufacturing Practices) and quality assurance procedures.
• Proficiency with Microsoft Office applications and other computer software programs.
• Ability to manage multiple priorities and meet deadlines.
• Strong written and verbal communication skills.
• Ability to maintain confidentiality and handle sensitive information appropriately.
• Strong analytical and problem-solving abilities.
• Ability to interpret written procedures, technical documents, and regulations.
• Ability to prepare reports and maintain accurate records.

Preferred Experience

• 1-3 years of experience in a manufacturing, pharmaceutical, quality assurance, or other regulated environment preferred.
• Experience with environmental monitoring, quality documentation, or GMP-regulated operations is a plus.