Analytical Quality Assurance (AQA) Associate
Analytical Quality Assurance (AQA) Associate
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1 Vacancy
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: $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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Employment Type
Full-time
