QA Associate
RK Pharma
- Pearl River, New York, United States
- Pearl River, New York, United States
À propos
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
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
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.
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Compétences linguistiques
- English
Avis aux utilisateurs
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