pharmaceutical Quality Assurance Associate
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Job Location:
Hauppauge, NY - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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
- Bachelors 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.
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