pharmaceutical Quality Assurance Associate Job at Trispoke Managed Services Pvt Ltd, Hauppauge, NY

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  • Trispoke Managed Services Pvt Ltd
  • Hauppauge, NY

Job Description

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

Job Tags

Full time, Currently hiring, Local area

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