Analytical Quality Assurance (AQA) AssociateTrispoke Managed Services Pvt Ltd • United States
Dieses Stellenangebot ist nicht mehr verfügbar
Analytical Quality Assurance (AQA) Associate
Trispoke Managed Services Pvt Ltd
- United States
- United States
Über
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
Sprachkenntnisse
- English
Hinweis für Nutzer
Dieses Stellenangebot wurde von einem unserer Partner veröffentlicht. Sie können das Originalangebot einsehen hier.