Aseptic Operator
at rk pharmaPearl River (NY)
About the role
Job Description:
About RK PharmaRK 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. We value people who take pride in careful work, respect procedures, and understand that consistency and attention to detail are essential in aseptic manufacturing environments.
About the Role:
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 escalate 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
What We’re Looking For:
- RequiredHigh 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 PPEDependable attendance and clear communication
- PreferredPrevious 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 WorkAt 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 PPEAbility 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 EmployerRK Pharma is an equal opportunity employer. We are committed to fair, consistent, and respectful hiring practices.
Requirements:
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