Analytical Quality Assurance (AQA) Associate Job at Trispoke managed services, Central Islip, NY

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  • Trispoke managed services
  • Central Islip, NY

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

#AnalyticalQualityAssurance #QualityAssuranceJobs #PharmaJobs #PharmaceuticalCareers #AQA #cGMP #GLP #GMP #QualityControl #ChemistryJobs #PharmaceuticalSciences #LabCompliance #FDARegulations #ICHGuidelines #AnalyticalChemistry #HPLC #GC #UVVis #DrugDevelopment #InhalationProducts #CentralIslipJobs #NewYorkJobs #USPharmaCareers

Job Tags

Full time, Contract work, Remote work, Relocation, Flexible hours, Afternoon shift,

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