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)
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
- 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
- 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
Vacancy posted 1 day ago
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