POSITION SUMMARY:

The QA Training Associate is responsible for assisting with training management both in Aspire LMS and Instructor-led training. The QA Training Associate will manage new hire onboarding training for CGMP and GDP. The QA Training Associate will maintain the Instructor-led training program including interfacing with off-site resources such as the community college, freelance instructors, and others as designated by the Director of ACT/QABR. The QA Training Associate will be responsible for scanning, cataloging and archiving all training documentation. The QA Training Associate will perform research to identify training opportunities and resources.

In addition to Training administration, the QA Training Associate will assist with Gowning Qualifications and Aseptic Practices monitoring in the manufacturing area. 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.

OVERALL JOB RESPONSIBILITIES:

FINANCIAL:

• 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.

OPERATIONAL EXCELLENCE:

• Assist in maintaining training program including but not limited to curriculum, completion of training etc. through LMS.
• Coordinate external and internal training resources and maintain training records throughout the document lifecycle.
• 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.
• When necessary document and initiate review into any incidents related to the aseptic process that occur.
• Partner with Production, QA and QC staff in supporting the investigation of events linked to microbial contamination and in particular, defining CAPA’s associated with human aseptic practices.
• Assist with monitoring Aseptic Process Simulation (APS) Media Fills
• 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.
• Partner with Operational and Environmental Control staff

STAKEHOLDER:

• Ensure compliance with Standard Operating Procedures (SOPs), Forms, Batch Production Records, Protocols, as needed.

INNOVATION:

• Operate in compliance of cGMP, 21CFR, USP, EP and ICH regulatory requirements.
• Based on QMR trends, provide training support to address issues related to Aseptic Practices, EM/PM, BPR errors, etc.

KNOWLEDGE, SKILLS AND ABILITIES:

Education:

Requires Bachelor's Degree preferably in a scientific field, such as Microbiology

Experience:

• 3+ years of experience in an aseptic manufacturing environment preferred
• Training experience is essential

Knowledge and Skill:

• Knowledge of current cGMP regulations.
• Proficient in Windows, Microsoft Word, Excel and PowerPoint.
• Good written, verbal, and communication skills.
• Good documentation skills.
• Strong organizational skills.
• Time management
• 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.