Aseptic Filling Training Associate
About The Position
The Aseptic Filling Training Associate oversees aseptic manufacturing processes, providing quality control and operational support in the aseptic core. The role ensures compliance with current Good Manufacturing Practices (cGMP) and provides real-time oversight and training to help maintain product quality and safety. The associate monitors aseptic manufacturing activities, observes gowning and aseptic technique, documents and trends performance, supports investigations, and helps deliver training and qualification activities. The position also coaches personnel, partners with Operations and Quality, and serves as a site subject matter expert and escalation point for aseptic processing and contamination control training.
Requirements
- High school diploma required.
- At least 5 years working in and/or supporting aseptic operations under cGMP scrutiny.
- Experience with aseptic operations including cleaning and sanitization, sterilization, aseptic gowning, aseptic technique and operating principles, non-conformance investigation, process validation, environmental testing, and equipment operation in an aseptic environment.
- Familiarity with applicable aseptic processing guidance, such as FDA CFR and EU GMP Annex 1.
- Strong communication, conflict-resolution, and critical-thinking skills.
- Detail-oriented and highly organized.
- Effective problem-solving skills and proven leadership and team-development abilities.
- Applicants must be authorized to work for any employer in the United States; visa sponsorship or takeover of sponsorship is not available.
Nice To Haves
- Associate or bachelor’s degree in science (such as Microbiology) or a related field.
Responsibilities
- Monitor and support aseptic manufacturing activities to ensure compliance with SOPs and cGMP requirements, correcting or escalating issues as they occur.
- Observe personnel performing aseptic gowning and provide immediate positive or constructive feedback, including instructing personnel to restart the process when needed.
- Record, track, and review data, completing documentation in accordance with cGDPs.
- Support investigations into aseptic technique deviations, contamination events, and environmental monitoring trends.
- Support instructor-led training, practical demonstrations, virtual reality modules, and hands-on assessments.
- Support new-hire qualifications, annual recertification, and retraining for aseptic core personnel.
- Observe and document aseptic technique performance during media fill simulations.
- Trend and report data on aseptic gowning, aseptic technique, cleanroom behaviors, and contamination control; ensure coaching, corrective actions, and follow-up training are completed and effective.
- Provide immediate feedback, corrective-action training, and mentorship to aseptic core personnel.
- Work with Operations, Quality, and other departments, communicating openly and escalating matters when necessary.
- Improve team knowledge of microbiological science, control strategies, monitoring programs, and their impact on aseptic processing.
- Serve as the site subject matter expert and escalation point for aseptic processing and contamination control training; partner with Team Leads and Group Leads to identify training needs and agree on remediation plans.
- Promote teamwork and collaboration to support continuous improvement and a Right First Time (RFT) mindset.
- Support departmental projects and perform other tasks and duties as assigned.
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What This Job Offers
Job Type
Full-time
Education Level
High school or GED
