Job Description
Job Title: Analytical Quality Assurance (AQA) Associate II/III
Location: Central Islip, NY (Onsite)
Employment Type: Full-time | Contract-to-Hire
Salary Range: $65,000 - $90,000 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 - Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field (Master's 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 Bachelor's (Master's 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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Job Tags
Full time, Contract work, Relocation, Flexible hours, Afternoon shift