Aseptic Compliance & Training Associate
Location
Monroe, NC | United States
Job description
The Aseptic Compliance and Training Associate is responsible for monitoring the day to day activities on the shop floor of the aseptic manufacturing area. This position will be responsible for ensuring that all activities associated with aseptic manufacturing practices are carried out in compliance with cGMPs, and all company policies, SOPs, forms, and other Regulatory and Safety requirements. The Aseptic Compliance and Training Associate will assist with new hire Aseptic technique training and certification as well as ongoing training, retraining, and certification of employees working in the aseptic manufacturing area. This role will be the eyes and ears of the Aseptic Compliance and Training Department during the routine day today activities taking place in the aseptic manufacturing area. This position will provide guidance and feedback on any activities that are potential issues either due to human error or process design, or process failure. This role will work closely with members of other teams (IPQA, Production, Engineering, Microbiology, Etc.) to ensure that aseptically sound work is performed to prevent any potential product impact or personal injury.
RESPONSIBILITIES
- Maintain quality system controls to ensure no critical and major market complaints
- Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency.
- Assist with the aseptic behavior certification program for employees working in the manufacturing aseptic environment including operational staff, cleaning staff, microbiology and maintenance staff, etc.
- Hands-on trainer for aseptic behavior inside the aseptic/classified manufacturing areas.
- Monitor day to day activities in the aseptic manufacturing area to ensure compliance with GMPs, Policies, SOPs, and other Regulatory requirements.
- When necessary document and initiate review into any incidents related to the aseptic process that occur.
- Monitor Aseptic Process Simulation (APS) Media Fills
- Provide aseptic technique support during smoke studies.
- Assist with GMP training modules related to proper aseptic behavior and maintaining an aseptic environment.
- Maintain working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing. Assess work environment to ensure it is suitable to enable good aseptic behaviors and makes recommendation to management on changes needed.
- Assist in maintaining training program including but not limited to curriculum, completion of training etc. through LMS.
- Partner with Operational and Environmental Control staff in supporting the investigation of events linked to microbial contamination and in particular, defining CAPA’s associated with human aseptic practices.
- Ensure compliance with Standard Operating Procedures (SOPs), Forms, Batch Production Records, Protocols, as needed.
- Operate in compliance of cGMP, 21CFR, USP, EP and ICH regulatory requirements.
- Based on daily process observations provide input regarding upgrades and improvement of procedures, and process/facility design.
External Interfaces
Regulatory agencies
USFDA
3+ years of experience in an aseptic manufacturing environment preferred
Experience in an aseptic environment or supporting aseptic manufacturing preferred.
Training experience is essential
Knowledge and Skills
- Knowledge of current cGMP regulations.
- Proficient in Windows, Microsoft Word, Excel.
- Good written, verbal, and communication skills.
- Good documentation skills.
- Strong organizational skills.
- Time management
- Requires thorough/working knowledge of GMP's, PICS and ISO and expertise in sterile processing. Must have demonstrated ability to handle multiple projects in a dynamic environment.
- Must be able to take complex principles and concepts and break them down into teachable elements so colleagues can quickly understand.
Job tags
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