Trispoke Managed Services Pvt. Ltd. · 1 day ago
pharmaceutical Quality Assurance Associate
Hauppauge, NY
Full-time
Onsite
Entry, Mid Level
$72K/yr - $93K/yr
2+ years expTrispoke Managed Services Pvt. Ltd. is currently hiring for an onsite QA Associate (IT) position based in Hauppauge, NY. The QA Associate will be responsible for reviewing Batch Production Records and ensuring compliance with GMP and regulatory requirements, playing a critical role in maintaining documentation accuracy and overall product quality.
Outsourcing/Offshoring
No H1B
U.S. Citizen Only
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
Qualification
Required
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)
Preferred
Local candidates preferred
Company
Trispoke Managed Services Pvt. Ltd.
Established in 2022 with an Idea to provide Cost Effective, Best Quality and Tailor Made services to Clients in field of US Staffing, Recruitment, Medical Billing, Staff Augmentation, Customer Support, Virtual Assistant, Accounting and Book-Keeping.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase