Aseptic Compliance Coordinator

Aseptic Compliance Coordinator

The Aseptic Compliance Coordinator will support development and implementation of aseptic training programs/initiatives, focused on ensuring compliance within the cleanroom environment. This role will be responsible for maintaining the Aseptic Observation Program including observation execution, trend analysis, and escalation of adverse trends.

Essential Duties and Responsibilities

• Explore opportunities for cleanroom enhancements and process improvements related to Aseptic Technique.
• Responsible for creating and maintaining Nephron Aseptic University certifications.
• Responsible for Standard Operating Procedure (SOP) review, revision, and creation related to aseptic techniques, Nephron's aseptic training curriculum, and routine cleanroom observations.
• Serve as subject matter expert (SME) on initial training and re-certifications, smoke studies, media fills, and aseptic observations to ensure adequate knowledge of the process and familiarity with procedure.
• Participate in quality risk assessments associated with aseptic processing, contamination control, facility changes, and process improvements.
• Trend aseptic observation findings, gowning deficiencies, and intervention practices.
• Review environmental monitoring trends and correlate findings with observed operator practices.
• Assist with the design and development of organizational training programs, tools, and processes to build Quality in the cleanroom.
• Maintain knowledge of FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing, EU GMP Annex 1, USP, and internal Contamination Control Strategy requirements.
• Provide assessment and guidance on growing program to ensure a robust process.

Supplemental Functions

• Support cleanroom departments with investigations, audit responses, process improvements and training for deviations, as well as the subsequent Corrective and Preventive Actions (CAPAs), specifically involving aseptic practices, personnel monitoring excursions, environmental monitoring events, contamination risks, and sterility assurance concerns.
• Work collaboratively with various operational areas to reduce instances of poor Aseptic practice and quality-related investigations.
• Ensure timely project completion for cleanroom-related process improvements.
• Assists with additional work duties as evident or required.
• Copying, filing, and scanning of documents.

Job Specifications and Qualifications

Knowledge & Skills

• Technical background preferred, with knowledge of cGMP, and FDA regulations.
• Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization.
• Proficient in managing Dot Compliance document revisions, E/Ps, approvals, timelines, and assignments.
• Strong interpersonal, verbal, and written communication skills; effective organization, multi-tasking, and problem-solving skills.
• Must be certified to enter aseptic environments around the facility, including ISO 5.
• Great communication, documentation, and time management skills required.
• Computer experience (Microsoft Word, Excel, Power Point).
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals.
• Possesses initiative and follow through to implement, track, and achieve on-time completion of projects, as assigned by management.
• Must strive for continuous improvement in all work activities.
• The ability to take strategic objectives and accept accountability, motivate and influence others, thinks globally, and leverages diversity.
• Additional Requirements: As needed

Education/Experience

• Bachelor's degree in Microbiology, Biology, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline preferred.
• Minimum of 1–3 years of experience in pharmaceutical manufacturing, quality systems, sterility assurance, microbiology, or a related GMP-regulated environment.
• 1-2 years of pharmaceutical experience in quality systems preferred
• Working knowledge of current cGMP requirements, applicable USP chapters, and 21 CFR regulations related to pharmaceutical manufacturing and aseptic processing.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint
• Hands on experience in aseptic programs including Clean Room Qualification and Environmental Monitoring. (Experience in 503b outsourcing facilities is preferred, not required).
• Hands-on experience supporting aseptic processing programs, including cleanroom qualification, environmental monitoring, personnel monitoring, aseptic technique, and contamination control activities preferred
• Experience working in a 503B outsourcing facility is preferred but not required.

Working Conditions / Physical Requirements

• Position requires typing, climbing, lifting (up to 15lbs), reaching, vision (20/20), standing (25%), sitting (75%), walking, and hearing