Analytical QA Associate I - DPI

Job Title: QA Associate I AQA

Location: Hauppauge, NY

FLSA Classification: Professional, Exempt

Reports To: Quality Assurance Supervisor

Salary Range: $76,000 - $85,000

The Analytical Quality Assurance (AQA) Associate I is a team contributor role focused on ensuring compliance and quality across raw materials, in‑process, and finished product analytical documentation. The role supports laboratory operations under current Good Laboratory Practices (cGLP) and collaborates with cross‑functional teams to maintain rigorous standards.

• Reviewing and confirming compliance related to raw materials, in‑process and finished product analytical documents.
• Monitoring and ensuring adherence to cGLP by laboratory personnel during routine operations.
• Verifying laboratory chemicals/reagents and standards for label completeness against standard operating procedures (SOPs).
• Reviewing laboratory audit trails during data review against SOPs.
• Coordinating with the Analytical Laboratory Teams to arrange required documents for cross‑functional teams.
• Maintaining all incoming documents with proper tracking, recording, storage, and archival.
• Identifying gaps within the system during routine monitoring and informing the supervisor of necessary improvements.
• Actively participating in reviews of data related to laboratory investigations and incidents, ensuring proper compliance.
• Performing other departmental and cross‑functional projects and assignments assigned by the manager/supervisor.

• Minimum bachelor’s degree in chemistry, pharmaceutical sciences, or related field. Master's degree preferred.
• 1‑3 years of experience in analytical quality assurance.
• Proficiency in computer skills and software applications such as Microsoft Office and Quality management systems.
• Knowledge of analytical laboratory activities including API, drug products, analytical development, QC, GLP/GMP/GDP.

• Understanding of laboratory equipment operation, qualification, and calibration reviews (e.g., pH meter, conductivity meter, analytical balance, UV‑Vis, IR).
• Effective interpersonal relationship skills and ability to work in a team environment.
• Experience in inhalation products (DPI) is a plus.
• Ability to work in a fast‑paced, dynamic manufacturing environment.
• Clear communication across all levels, strong documentation and technical writing skills.
• Ability to work independently and under minimal supervision.

• Proficient in English; reading, writing, speaking, and interpersonal communication.
• Self‑starter with initiative to seek training or direction as needed.
• Willingness to work any assigned shift, including first or second shift and occasional weekends.
• Knowledge of GMP and documentation practices preferred.
• Self‑motivated, detail oriented, and capable of handling multiple tasks simultaneously.

• General shift with flexibility for first or second shift; schedules include Monday‑Friday, Tuesday‑Saturday, or combinations based on business needs.
• Willingness to work weekends as required.
• Relocation negotiable; no remote work available.
• Laboratory environment requires personal protective equipment (PPE) such as lab coats, safety glasses, respiratory protection, hearing protection, etc.
• Work may be assigned on a shift basis (Day, Evening, Night). Weekend or holiday work may be requested based on business needs.