Training Coordinator chez Isotopia USA

Description

Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. At our US headquarters in Indianapolis, we will be next door to our key customers, delivering our products just in time, each day, every day. We are seeking a highly motivated and detail oriented Training Coordinator to join our dynamic team. You will play a crucial role in ensuring the safe and efficient production of our products. You will be part of a family and team, dedicated to our mission to deliver on our covenant with our customers.

Responsibilities:

• Coordinate, administer, and maintain the site Training Program in compliance with FDA 21 CFR Parts 210/211, EU GMP, ICH Q10, and applicable radiopharmaceutical regulations
• Develop, implement, and maintain GMP training curricula for all functional areas, including manufacturing, quality, materials and logistics, QC, radiation safety, and support functions
• Manage initial, continuing, and job-specific training for employees, contractors, and temporary staff prior to performing GMP or radiation-related activities
• Ensure training requirements are defined and maintained within the Quality Management System (QMS), including role-based curricula and training matrices
• Schedule, track, and document GMP, safety, and radiation protection training to ensure completion within required timelines
• Maintain accurate, contemporaneous training records in paper-based and/or electronic training management systems in accordance with data integrity principles (ALCOA+)
• Support the creation, review, and approval of training materials, SOPs, work instructions, and training assessments in collaboration with Subject Matter Experts (SMEs)
• Coordinate training effectiveness evaluations, including knowledge checks, quizzes, on-the-job training (OJT) verification, and periodic retraining
• Support onboarding and qualification of personnel for new processes, equipment, facilities, and validated systems
• Track training metrics and KPIs, identify gaps or overdue training, and proactively escalate risks to management
• Support regulatory inspections and audits by preparing training documentation and responding to inspector inquiries
• Participate in deviation investigations, CAPAs, and change controls related to training deficiencies or process changes
• Ensure training requirements are updated and implemented following SOP revisions, process changes, or regulatory updates
• Coordinate site-wide GMP refresher training and annual mandatory training programs
• Collaborate with Quality Assurance, Radiation Safety, and Operations to ensure training aligns with contamination control, aseptic behavior (where applicable), and radiological safety expectations
• Perform other related duties as assigned by management

Requirements

• Associates Degree is required. Bachelor’s degree in Life Sciences, Chemistry, Engineering, Education, Quality, or a related scientific or technical discipline is an asset.
• Minimum 1–3 years of experience in a GMP-regulated pharmaceutical, radiopharmaceutical, biotechnology, or API manufacturing environment
• At least 2–4 years of direct experience coordinating, administering, or supporting GMP training programs
• Working knowledge of FDA 21 CFR Parts 210/211, EU GMP, and ICH Q10 principles
• Hands-on experience with training documentation systems, including paper-based or electronic LMS/eQMS platforms
• Experience developing or coordinating role-based curricula, training matrices, and training effectiveness assessments
• Demonstrated experience applying data integrity principles (ALCOA+) to training records
• Ability to interpret regulatory requirements and translate them into practical, compliant training programs
• Knowledge of training effectiveness methodologies, including OJT qualification, assessments, and periodic requalification
• Excellent organizational skills with the ability to manage multiple training programs, deadlines, and stakeholders simultaneously
• Strong attention to detail with the ability to identify training gaps, risks, and compliance issues proactively
• Ability to track and trend training metrics and provide clear reporting to management
• Clear, professional written and verbal communication skills suitable for regulated documentation and inspector interactions
• Ability to work cross-functionally with Quality, Manufacturing, Engineering, QC, and Radiation Safety teams
• Confidence engaging with SMEs and leadership to define training needs and resolve training-related issues
• High level of integrity and accountability with a strong quality mindset
• Ability to work independently while knowing when to escalate compliance risks
• Adaptability in a fast-paced, startup or growth-stage manufacturing environment
• Continuous improvement mindset with the ability to identify opportunities to enhance training effectiveness and compliance

Benefits

We offer a competitive salary, a comprehensive package of benefits, and advancement opportunity.

As an equal opportunity employer, we are committed to a diverse workforce.