Analytical Quality Assurance; AQA Associate

Position: Analytical Quality Assurance (AQA) Associate
Location: Islandia

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

#Analytical Quality Assurance  #Quality Assurance Jobs  #Pharma Jobs #Pharmaceutical Careers #AQA #cGMP #GLP #GMP #Quality Control #Chemistry Jobs #Pharmaceutical Sciences #Lab Compliance #FDA Regulations #ICHGuidelines #Analytical Chemistry #HPLC #GC #UVVis #Drug Development #Inhalation Products #Central Islip Jobs  #New York Jobs  #USPharma

Careers