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.

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Job Tags

Full time, Currently hiring, Local area, Remote work

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