QA Associate in Pearl River, New York at RK PHARMA INC

About RK Pharma
RK Pharma is a pharmaceutical organization dedicated to delivering high-quality, affordable drug products through disciplined execution and strong internal collaboration. Our work is not patient-facing, but it directly supports the safety, reliability, and compliance of products relied upon downstream.

We value people who take pride in careful work, respect quality systems, and understand that consistency and sound judgment matter more than speed or spotlight.

About the Role
The QA Associate supports production-related quality activities to ensure processes, data, and documentation meet GMP and regulatory expectations. This role works closely with Microbiology, Manufacturing, and other Quality functions to help maintain a state of control across facilities and systems.

This position is well-suited for someone with a microbiology background who is detail-oriented, thoughtful, and comfortable working within structured quality systems. Success comes from steady judgment, clear communication, and the confidence to ask questions or raise concerns when something does not look right.

Key Responsibilities

• Provide Quality Assurance support and oversight for microbiology-related activities, including environmental monitoring and utility monitoring
• Review microbiology data, records, and reports for accuracy, completeness, and GMP compliance
• Support investigations related to microbial excursions, deviations, and OOS/OOT results Assist with CAPAs, change controls, and risk assessments that impact microbiology systems
• Ensure documentation is completed clearly, accurately, and in accordance with approved procedures
• Participate in internal audits, inspections, and readiness activities as needed
• Collaborate with Microbiology, Manufacturing, Validation, and broader Quality teams
• Escalate quality concerns promptly and appropriately through established channels

What We’re Looking For

Required:

• Bachelor’s degree in Microbiology, Biology, or a related scientific discipline Experience in a GMP-regulated pharmaceutical, biotechnology, or similar environment
• Working knowledge of microbiology concepts such as environmental monitoring, contamination control, and aseptic practices Strong attention to detail and disciplined documentation habits
• Ability to follow established procedures and quality systems Clear written and verbal communication skills

Preferred

• Prior experience in Quality Assurance or QC
• Familiarity with cleanroom operations and environmental monitoring programs
• Experience supporting audits or regulatory inspections

How We Work

At RK Pharma, quality takes priority over speed. Procedures are followed for a reason. Questions and escalation are encouraged. Helpfulness and respect are expected across teams. No one is asked to cut corners to meet a deadline. People who do well here are steady, thoughtful, and comfortable letting the quality of their work speak for itself.

Physical and Work Environment

Requirements Ability to work in controlled environments, including cleanrooms as required

Ability to review data and documentation for extended periods Compliance with gowning, hygiene, and safety requirements

What We Offer

A stable, quality-focused work environment Clear expectations and structured onboarding Collaboration with experienced Quality professionals The opportunity to directly support product quality and compliance

Equal Opportunity Employer RK Pharma is an equal opportunity employer. We are committed to fair, consistent, and respectful hiring practices.