Microbiology Trainer I

Core Hours: Monday - Friday, 8am-5pm

Purpose and Scope

Responsible for delivery of training for all quality control microbiology test methods including raw materials, finished product, bulk water, EM and stability samples to the QCM team. Responsible for creating, revising implementing and archiving training processes and training material to ensure that the training provided to the team is comprehensive and current to applicable cGMP standards, and will monitor its effectiveness.

Essential Duties & Responsibilities

• Schedule and monitor training of new employees to ensure a smooth transition into the laboratory.
• Serve as Trainer for the QC Microbiology Lab including the delivery of training on technical topics to the QCM team.
• Perform training of all new hires, including skills verification, basic documentation, and LIMS/ MODA use.
• Mentor and train junior analysts in a variety of sample preparations and lab techniques.
• Mentor analysts in day to day testing and documentation after training to ensure retention of training materials and demonstration of best practices.
• Assist newly trained analysts in troubleshooting methods or instrumentation.
• Design and maintain a robust onboarding and training program for new hires to the QCM team.
• Develop and deliver technical training as required in relation to microbiology and aseptic techniques.
• Support the introduction of new methods/techniques/technologies into the QCM Lab.
• Manage the training program for QCM including planning and facilitating workshops and supporting the translation of the output to procedural/process updates.
• Create and maintain up to date training matrices for each applicable site.
• Documentation flow and paperwork practices - Improving Right First Time and reducing GDP errors within QCM through training improvements.
• Develop simplified and effective scheduling for training activities to maximize available resources.

• Coach and train new and existing employees on the knowledge and skills required for job function.
• Partner with management to review and update employee training matrices in the ELMS.
• Gather data about training metrics and work with management to ensure efficiencies, effective learning outcomes and continuous improvement.
• Assist microbiology management in ensuring training requirements are met for new and existing employees prior to performing job tasks.
• Provide in person coaching to employees post-training to ensure retention of training materials and demonstration of best practices through training audits and GEMBA's.
• Facilitate the regular review and updating of training materials.
• Audit training records to ensure complete and accurate recording of employee training documentation.
• Serve as department Learning Administrator for microbiology employees ensuring accurate assignment, recording and documentation of training activities in the Electronic Learning Management System (ELMS).
• Maintain qualification as a trained trainer and assessor and work with management and L&D to ensure adequate trainer and assessor availability across all shifts and locations.
• Identify continuous improvement opportunities for departmental training materials and processes. Coordinate with Subject Matter Experts (SMEs) and L&D to develop and update them.
• Ensure documentation of all activities and maintain training records according to good documentation practices data integrity and ALCOA+.

• Assist with the preparation and maintenance of employee skills matrices for the purpose of identifying skill gaps and planning training activities.
• Provide support to department leadership with the implementation of ELMS enhancements and other continuous improvement efforts.
• Upon delegation, may be responsible for representing the QC Microbiology laboratory when communicating with outside departments. Provide support to the department leadership with the implementation of new training systems and related continuous improvement efforts. Generate new ideas to create efficiencies and improve processes; willingly support new ideas and process enhancements.
• Prioritize tasks and perform job duties with guidance from management. Work to complete tasks in an efficient manner, and serve as a productive member of the department. Contribute to a highly productive environment by avoiding distractions.
• Maintain compliance to all Tolmar health and safety policies, as well as OSHA standards.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.
• Exhibit a positive and understanding attitude at all times.
• Interact respectfully with all other employees both inside and outside of the department and members of management, and shows interest in others' input and reasoning. Appropriately resolve differences of opinion.
• Identify issues and possible solutions and escalate those issues and solutions to the department senior leadership or management as appropriate.
• Demonstrate leadership in compliance and data integrity. Demonstrate leadership aptitude in technical functions.
• Participate in required monthly safety trainings and annual HAZ-COM, biohazard, RCRA and API handling trainings. Hazardous waste involvement may include but is not limited to making waste determinations, generation, transportation, satellite accumulation, storage and disposal of multiple types of waste streams, and container management and inspections. Respond to spills per company procedure. Maintain compliance to all Tolmar health and safety policies, as well as OSHA standards.
• Perform other duties as assigned.

Knowledge, Skills & Abilities

• Competent in the knowledge and application of federal cGMP regulations and their application to laboratory testing and review of processes and procedures.

• Continuous learning mindset and willingness to adapt to evolving technologies and industry best practices.
• Demonstrates strong learning agility and ability to translate effectively to others.
• Maintains environment conducive to learning and creates conditions for the successful transfer of learning. Demonstrated ability to communicate complex and technical information clearly and cohesively to variety of audiences.
• Demonstrated experience delivering training and actively coaching others on a variety of job tasks such as job specific skills, documentation and GMPs.
• Ability to maintain an environment conducive to learning and create conditions for the successful transfer of learning.
• Proficient with training and mentoring junior analysts.
• Well versed in laboratory instrumentation and aseptic technique.
• Effective written and oral communication skills.
• Ability to interpret, understand and follow new learning and teaching techniques.
• Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in order to meet important timelines in a high throughput manufacturing.

Core Values

• The Microbiology Trainer I is expected to operate within the framework of Tolmar's Core Values:

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  • Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
  • Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
  • Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
  • Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
  • Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.
  
  
  
  

Education & Experience

• Bachelor's degree in scientific discipline, education or related field.
• Three or more years of experience in a GMP microbiology laboratory environment required.
• Previous experience in technical training capacity strongly preferred.

Working Conditions

• Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in order to meet important timelines in a high throughput lab.
• Business demands may present a need to work extended hours, and or across multiple shifts and locations.
• Manufacturing working conditions, which include extended standing for long periods.

Compensation and Benefits

• Annual pay range $71,000 - $76,000 depending on experience
• Benefits information: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.