Analytical Quality Assurance (AQA) Associate

Job Title: Analytical Quality Assurance (AQA) Associate II/III
Location: Central Islip NY (Onsite)
Employment Type: Full-time Contract-to-Hire
Salary Range: $65000 $90000 per annum
Work Hours: 8:30 AM 5:00 PM (may vary per business needs)
Citizenship Requirement: US Citizen or Green Card Holder

About the Role

We are seeking an Analytical Quality Assurance (AQA) Associate II/III with a strong analytical chemistry/lab background to join our Quality team. The role involves ensuring compliance with cGLP reviewing analytical documents and supporting laboratory operations to maintain the highest quality standards.

Key Responsibilities

• Review raw material in-process and finished product analytical documentation for compliance.
• Monitor laboratory practices to ensure adherence to cGLP and SOPs.
• Confirm compliance of method validations verifications and study reports.
• Prepare/review laboratory investigations (OOS/OOT/Deviation) reports.
• Verify laboratory chemicals/reagents and standards per SOPs.
• Assess and implement changes from Pharmacopoeia editions/updates.
• Review audit trails and data against SOPs.
• Coordinate with Analytical Laboratory Teams to support cross-functional requirements.
• Maintain accurate document tracking storage and archival.
• Identify process/system gaps and recommend improvements.
• Participate in laboratory incident reviews to ensure compliance.

Required Qualifications

• Bachelors degree in Chemistry Pharmaceutical Sciences or related field (Masters preferred).
• 4 8 years of analytical experience with at least 3 years in Analytical Quality Assurance.
• Strong knowledge of APIs drug products QC GLP GMP GDP and USP monograph requirements.
• Proficiency with laboratory equipment and software (HPLC GC UV-Vis Spectrophotometer Potentiometer pH meters Stability Chambers etc.).
• Familiarity with FDA and ICH guidelines.
• Excellent communication documentation and technical writing skills.
• Ability to work independently with minimal supervision in a cGMP environment.

Preferred Skills

• Experience with inhalation products (DPI).
• Project management and cross-functional collaboration experience.
• Knowledge of laboratory audit trails data integrity and regulatory standards.

Work Environment

• Onsite cGMP laboratory/manufacturing setting.
• PPE required (lab coats safety glasses hearing protection respirators etc.).
• Must be flexible to work first or second shift; weekend/holiday work may be required.
• Relocation negotiable. Remote work is not available.

Must-Haves Checklist

Bachelors (Masters preferred) in Chemistry/Pharma Sciences
4 8 years in analytical with 3 years in AQA
Hands-on experience with lab equipment & compliance systems
Strong knowledge of USP FDA ICH guidance
Excellent documentation reporting and communication skills

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