Aseptic Operator

RK Pharma Inc; Pearl River (NY); On-site; USD 40,000 - 55,000; Full time

Benefits offered by this job

Stable work environment

Structured training

Hands-on experience in sterile manufacturing

Job summary

RK Pharma Inc in Pearl River, NY is hiring an Aseptic Operator responsible for supporting sterile manufacturing operations through aseptic processing activities. The role requires detail-oriented individuals who can follow strict procedures in cleanroom environments. Responsibilities include performing aseptic actions, monitoring conditions, and ensuring compliance with GMP. Preferred candidates have experience in sterile manufacturing and follow thorough documentation practices. We offer a stable work environment focused on product quality and compliance.

Qualifications

• Experience in GMP-regulated manufacturing, preferably sterile processing.
• Comfortable working in cleanroom environments with PPE.
• Strong documentation accuracy and detail orientation.

Responsibilities

• Perform aseptic manufacturing activities following SOPs and GMP.
• Monitor process conditions for compliance with aseptic techniques.
• Participate in training and continuous improvement activities.

Skills

Attention to detail

Ability to follow procedures

Communication skills

Dependable attendance

Education

High school diploma or equivalent

Job description

About RK Pharma

RK Pharma is a pharmaceutical organization focused on delivering high-quality, affordable drug products through disciplined execution and strong internal collaboration. While we are not patient-facing, our work directly supports product safety, reliability, and compliance across regulated pharmaceutical operations.

Role Overview

The Aseptic Operator is responsible for supporting sterile manufacturing operations by performing aseptic processing activities in compliance with GMP requirements. This role plays a critical part in maintaining product quality and contamination control within cleanroom environments. This position is well-suited for someone who is detail-oriented, dependable, and comfortable working within strict procedures and controlled conditions. Success in this role comes from focus, consistency, and the willingness to stop and escalate when something does not look right.

Key Responsibilities

• Perform aseptic manufacturing activities in accordance with approved SOPs and GMP requirements
• Follow gowning, hygiene, and contamination control procedures required for cleanroom operations
• Set up, operate, and monitor manufacturing equipment used in aseptic processes as trained
• Accurately complete batch records, logs, and other production documentation in real time
• Monitor process conditions and product handling to ensure compliance with aseptic technique
• Identify and elevate deviations, equipment issues, or potential contamination concerns promptly
• Participate in cleaning, sanitization, and line clearance activities
• Support environmental monitoring and sampling activities as required
• Work collaboratively with Manufacturing, Quality Assurance, and support teams
• Participate in training, qualification, and continuous improvement activities

Qualifications

• High school diploma or equivalent
• Experience working in a GMP-regulated manufacturing environment, preferably sterile or aseptic processing
• Ability to follow detailed procedures and instructions consistently
• Strong attention to detail and documentation accuracy
• Comfort working in cleanroom environments while wearing full gowning and PPE
• Dependable attendance and clear communication

Preferred Qualifications

• Previous experience in aseptic filling, sterile compounding, or sterile manufacturing operations
• Familiarity with cleanroom classifications and aseptic technique principles
• Experience supporting inspections or audits in regulated environments

How We Work

At RK Pharma, quality takes priority over speed. Procedures are followed for a reason. Questions are encouraged, and escalation is expected when conditions or results are not aligned. Helpfulness, respect, and calm collaboration are part of how we operate every day. People who succeed in this role are steady, focused, and comfortable letting careful work speak for itself.

Physical and Work Environment Requirements

• Ability to work standing or seated for extended periods
• Ability to perform repetitive tasks with sustained focus
• Ability to work in cleanrooms with required gowning and PPE
• Ability to lift, move, or handle materials as required by the role
• Compliance with safety, hygiene, and site requirements

What We Offer

• A stable, quality-focused work environment
• Clear expectations and structured training
• Hands‑on experience in sterile manufacturing operations
• The opportunity to contribute directly to product quality and compliance

Equal Opportunity Employer

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