pharmaceutical Quality Assurance Associate

Trispoke Managed Services Pvt Ltd

We are currently hiring for an onsite QA Associate (IT) position based in Hauppauge, NY . This is a full-time, salaried opportunity within a regulated pharmaceutical manufacturing environment.

Role Details

Location: Hauppauge, NY (Onsite)
Work Hours: 8:30 AM - 5:00 PM
Employment Type: Full-Time, Salaried (Exempt)

Position Overview

The QA Associate (IT) will be responsible for reviewing Batch Production Records (BPRs) and associated documentation to ensure full compliance with GMP , regulatory requirements, and internal quality systems. This role plays a critical part in maintaining documentation accuracy, audit readiness, and overall product quality.

Key Responsibilities

Review Batch Production Records (BPRs), manufacturing instructions, protocols, and equipment logs for completeness and GMP compliance
Verify documentation accuracy, signatures, dates, and resolution of discrepancies prior to approval
Review, create, and revise BPRs, SOPs, and manufacturing-related documentation
Support internal and external regulatory audits (FDA, GMP inspections)
Review engineering and facility records (temperature/humidity data, calibration, preventive maintenance)
Conduct daily quality rounds on the shop floor to ensure GMP compliance
Escalate quality issues and discrepancies to QA management
Ensure assigned training completion and adherence to cGMP, SOPs, and safety requirements

Required Qualifications

Bachelor's degree in pharmacy, Life Sciences, Chemistry, or a related field
2-3 years of experience in pharmaceutical Quality Assurance , specifically Batch Record Review
Strong knowledge of GMP , FDA and EMA regulatory requirements
Experience with Electronic Document Management Systems (EDMS) (e.g., Master Control)
Audit and inspection readiness experience
Excellent attention to detail, documentation accuracy, and organizational skills

Important Requirements

Pharmaceutical or regulated life sciences background is mandatory
US Citizen or Green Card Holder required
This position is onsite only (no remote or hybrid option)
Local candidates preferred

If this opportunity aligns with your background and career goals, please share your updated resume along with your availability to discuss further.

#QAJobs #PharmaJobs #QualityAssurance #GMP #cGMP #BatchRecordReview #BPR #PharmaceuticalManufacturing #FDACompliance #EMA #RegulatedIndustry #LifeSciencesJobs #OnsiteJobs #HauppaugeNY #MasterControl #EDMS #AuditReadiness #QualitySystems #USCitizensOnly #LocalCandidates

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Vacancy posted 3 days ago

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