Training Specialist

August Bioservices • Nashville, TN

4d • Onsite

About The Position

The Training Specialist supports the Training Program by coordinating and delivering training that ensures employees are trained and qualified to perform manufacturing operations in compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulatory requirements. This role conducts New Hire Orientation training on GDP, ALCOA++ principles, and data integrity expectations, facilitates qualification on foundational manufacturing processes, supports the aseptic training program, and maintains training records in MasterControl to ensure they are complete, accurate, and inspection ready.

Requirements

• 2+ years of experience in pharmaceutical manufacturing, quality assurance, or training.
• Working knowledge of current Good Manufacturing Practices (cGMP).
• Strong understanding of Good Documentation Practices and ALCOA++ principles.
• Excellent communication, presentation, and coaching skills.
• Strong organizational and documentation skills.
• Ability to evaluate trainee performance and provide constructive feedback.
• Ability to work effectively with employees at all organizational levels.
• Proficiency in Microsoft Word, Microsoft Excel, and Microsoft PowerPoint.

Nice To Haves

• Bachelor's degree in education, Engineering, Scientific field, or related field preferred.
• Experience in aseptic manufacturing and contamination control preferred.
• Experience developing and delivering technical training preferred.

Responsibilities

• Conduct New Hire Orientation training related to Good Documentation Practices (GDP), ALCOA++ principles, and data integrity expectations.
• Coordinate and deliver instructor-led training for employees in classroom, practical, and on-the-job settings.
• Support onboarding, qualifications, and ongoing development of manufacturing personnel.
• Conduct hands-on qualification for foundational manufacturing activities, including line preparation and clearance, balances and scales, pH meter operation, solution preparation, material transfer, disinfecting of classified manufacturing areas, and other core manufacturing processes.
• Facilitate retraining and remediation activities when required to address performance gaps, deviations, or compliance issues.
• Maintain training records and supporting documentation in MasterControl, ensuring records are complete, accurate, and inspection ready.
• Coordinate qualification scheduling and monitor training and qualification completion.
• Assist in the development and revision of training materials, qualification documents, assessments, and instructional content.
• Complete qualification to serve as the designated backup instructor for the site's three-day aseptic manufacturing training program.
• Conduct routine behavioral and procedural observations in manufacturing areas as part of the Aseptic Observation Program.
• Enter observation data into dashboards or tracking systems to support trending, analysis, and continuous improvement.
• Assist with internal audits, client audits, and regulatory inspections by providing training documentation and demonstrating compliance with established training procedures.
• Identify and implement opportunities to improve training effectiveness, qualification efficiency, and employee competency.
• Perform other duties as assigned.

Benefits

• August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level