Training Specialist

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.

ESSENTIAL DUTIES & 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.

QUALIFICATIONS

Bachelor's degree in education, engineering, scientific field, or related field preferred. 2+ years of experience in pharmaceutical manufacturing, quality assurance, or training. Experience in aseptic manufacturing and contamination control preferred. Experience developing and delivering technical training preferred.

KNOWLEDGE, SKILLS, & ABILITIES

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. Ability to work on flexible schedules, including off‑shift and weekend support as needed.

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Prolonged periods of standing in a manufacturing area or sitting at a desk and working on a computer. Ability to lift, carry, push, or pull up to 40 lbs occasionally and up to 30 lbs frequently. Two‑person team lift or use of a mechanical assist device is required for loads exceeding 50 lbs. Able to gown for Grade A/B, Grade C/D and wear a respirator without any restrictions. 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. #J-18808-Ljbffr Augustbio