Associate Scientist/Sr. Specialist, QC Microbiology Trainer

Position Summary

The Sr. Specialist, Associate Scientist, QC Microbiology Trainer is responsible for supporting the qualification and ongoing development of personnel performing microbiology and environmental monitoring activities within the Cell Therapy QC laboratories. This role develops, coordinates, and delivers instructor-led and hands-on laboratory training using approved curricula, procedures, and qualification materials. The trainer partners with QC subject matter experts, laboratory management, and the site training organization to schedule training, maintain training laboratories and materials, monitor qualification progress, and ensure that training is documented in accordance with applicable procedures and cGMP requirements. The successful candidate will combine strong QC microbiology knowledge with effective facilitation, coaching, technical writing, and organizational skills to promote a compliant, consistent, and effective learning environment.

Shift: Sun - Wed 6:30am to 4:30pm

Key Responsibilities

• Deliver instructor-led, hands-on, and on-the-job training for QC microbiology and environmental monitoring methods.
• Qualify and mentor analysts on approved laboratory methods, procedures, aseptic practices, and applicable training requirements.
• Coordinate training schedules with QC management, laboratory personnel, qualified trainers, and subject matter experts.
• Support the development, revision, and periodic review of training curricula, qualification plans, presentations, job aids, assessments, and training materials.
• Ensure training is delivered and documented in accordance with approved procedures, curricula, and training materials.
• Support microbiology and environmental monitoring training for techniques that may include: Aseptic technique, Environmental monitoring, Sterility testing, Endotoxin testing, Gram staining, Growth promotion, qPCR, Other applicable microbiology methods.
• Maintain the microbiology and aseptic training laboratories, including equipment, supplies, training samples, and instructional materials.
• Facilitate initial, refresher, remedial, and continuing qualification training based on departmental needs.
• Support the evaluation of trainee knowledge and practical performance, and provide timely, constructive coaching.
• Track training activities, qualification progress, completion status, and applicable training metrics.
• Identify training gaps, recurring challenges, and opportunities to improve training effectiveness, laboratory readiness, and Right-First-Time performance.
• Author, review, and revise training documents, technical procedures, test methods, and other controlled documentation as assigned.
• Review training and laboratory documentation for completeness, accuracy, and compliance with applicable procedures and cGMP requirements.
• Maintain appropriate control and filing of training records and supporting documentation.
• Work collaboratively with QC Microbiology, Environmental Monitoring, Quality Assurance, site training, and other cross-functional partners.
• Support training-related investigations, deviations, CAPAs, continuous improvement efforts, and inspection-readiness activities, as assigned.
• Represent QC Training during internal audits, regulatory inspections, and cross-functional discussions when needed.
• Cross-train on additional QC laboratory methods or processes to expand training coverage.
• Promote a strong learning culture that supports technical proficiency, compliance, accountability, and continuous development.
• Perform other job-related duties as assigned.

Required Qualifications

Education and Experience

• Bachelor’s degree in microbiology, Biology, Biological Sciences, or a related scientific discipline with relevant QC, microbiology, laboratory, or training experience.
• An equivalent combination of education, laboratory experience, and technical training may be considered.
• Relevant experience in a pharmaceutical, biotechnology, cell therapy, or similarly regulated laboratory environment.
• Hands-on experience with QC microbiology, environmental monitoring, aseptic practices, or related laboratory methods.
• Experience training, coaching, qualifying, or mentoring laboratory personnel.
• Experience working within cGMP and applicable regulatory requirements.

Knowledge, Skills, and Abilities

• Strong working knowledge of QC microbiology laboratory operations.
• Strong understanding of aseptic technique and microbiological controls.
• Knowledge of cGMP requirements and pharmaceutical or biotechnology regulations.
• Ability to learn, perform, demonstrate, and teach laboratory methods consistently using approved procedures.
• Ability to translate complex technical information into clear and practical training.
• Strong presentation, facilitation, coaching, and interpersonal skills.
• Effective technical writing and documentation skills.
• Strong planning, organization, prioritization, and time-management skills.
• Ability to manage multiple training assignments and time-sensitive deliverables in a fast-paced environment.
• Strong attention to detail and commitment to accurate, complete, and compliant documentation.
• Ability to communicate training status, qualification risks, roadblocks, and support needs effectively.
• Demonstrated problem-solving skills and the ability to address both routine and complex training challenges.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Customer-focused mindset with a commitment to meeting trainee, laboratory, and stakeholder needs.
• Ability to provide constructive feedback and create a supportive learning environment.
• Proficiency with applicable learning management systems and standard business applications is preferred.

Preferred Qualifications

• Experience with environmental monitoring, sterility testing, endotoxin testing, Gram staining, growth promotion, qPCR, or other applicable microbiology methods.
• Experience developing laboratory curricula, qualification plans, assessments, presentations, or hands-on training materials.
• Experience supporting training metrics, qualification tracking, or training-effectiveness evaluations.
• Experience with laboratory information management systems or electronic learning management systems.
• Experience supporting deviations, investigations, CAPAs, audits, or regulatory inspections.
• Experience within a Cell Therapy QC environment.

Working Conditions

The position requires regular work in a laboratory environment. The role may involve working around biological materials, biohazardous materials, and chemical agents while following established safety procedures. The position requires the ability to demonstrate laboratory techniques and facilitate hands-on training. Schedule flexibility may be required to support laboratory operations, training demand, and urgent business needs.