Sr QC Trainer

About the role

This position serves as the primary trainer for Quality Control (QC) employees, focusing on training in quality control processes and test methods for raw materials, cleaning samples, bulk intermediates, and finished products, as well as stability samples. The role also involves administrative tasks such as training documentation and performance tracking.

Responsibilities

• Serve as “Learning Administrator” for accurate assignment, recording, and documentation of training activities in the Electronic Learning Management System (ELMS).
• Support SMEs, ELMS Administrators, and the Learning and Development Department to draft new training content, including Competency Based Training (CBT) where appropriate in the laboratory.
• Contribute to and track completion of training metrics, efficiencies, effective learning outcomes, and take ownership of continuous improvement.
• Schedule and monitor training of new employees to ensure a smooth transition into the laboratory.
• Perform onboarding training of all new hires, including skills verification, basic documentation, and LIMS use for reagents and instruments.
• Train QC employees at all levels in a variety of lab operations processes, sample preparations, safety practices, lab techniques, and instrumentation.
• Mentor analysts in day-to-day testing and documentation after training to ensure they are demonstrating best practices.
• Observe and work with analysts to improve turnaround times.
• Implement knowledge checks and requalification processes to ensure learners are retaining their training.
• Identify areas where new training modules and CBTs would benefit the department.
• Ensure all new employee training documents are current and revised as required.
• Complete periodic review of all CBTs and training documents to maintain life cycle management.
• Accountable for documenting all activities and maintaining records according to good documentation practices and ALCOA+.
• Support and maintain up-to-date training matrices for each applicable site.
• Track and trend training as it is planned and completed.
• Ensure compliance with all Training Procedures and Policies and maintain change control for all training records.
• 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.
• Provide scientific recommendations to management/technical writers regarding QC procedures as applicable.
• Complete technical reviews of applicable procedures.
• Complete tasks on time and with minimal errors.
• Follow all procedures applicable to job functions to ensure high quality of work.
• Mentor others in the department to ensure department maintains high standards for quality of work.
• Prioritize tasks and perform job duties with minimal 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.
• Participate in required monthly safety trainings and annual HAZ-COM, RCRA, and API handling trainings.
• Respond to spills per company procedure.
• 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.
• Remember to look at situations from all aspects.
• Interact respectfully with all other employees both inside and outside of the department and members of management, and show interest in others' input and reasoning.
• Appropriately resolve differences of opinion.
• Upon delegation, may be responsible for representing the QC chemistry laboratory when communicating with outside departments.
• A leader in compliance and data integrity.
• Demonstrate leadership aptitude in technical functions.
• Identify issues and possible solutions and escalate those issues and solutions to the department senior leadership or management as appropriate.
• Assist in quality investigations that involve training issues and work with investigators to develop and implement effective CAPAs.
• Review errors made by analysts in the lab and collaborate with department management and other leadership to create tangible improvements to processes that will prevent errors.
• Assist with testing, data review, and lab operations tasks to support business demand as needed.
• Perform additional duties as assigned.

Knowledge, Skills & Abilities

• Well versed in the knowledge and application of government regulations for drugs or medical devices including GMP, GLP, and ICH and their application to laboratory testing and review processes and procedures.
• Demonstrated learning agility and ability to translate effectively to others.
• Maintains environment conducive to learning and creates conditions for the successful transfer of learning.
• Demonstrated aptitude to train others regarding documentation practices and regulations.
• Proficient with training and mentoring junior QC employees.
• Educated in a scientific discipline, preferably in Chemistry or Biochemistry.
• Eight or more years of experience in an analytical laboratory position using advanced techniques and demonstrated proficiency with complex testing.
• Previous experience in technical training capacity strongly preferred.

Education & Experience

• Bachelor’s degree in scientific discipline, preferably in Chemistry or Biochemistry.
• Eight or more years of experience in an analytical laboratory position using advanced techniques and demonstrated proficiency with complex testing.
• Previous experience in technical training capacity strongly preferred.

Core Values

• Center on People: Support the well-being of patients and treat employees and those served as valued partners.
• Are Proactive & Agile: Embrace a hands-on approach to adapt to change and respond swiftly and efficiently.
• Act Ethically: Conduct business ethically, comply with laws, and promote diversity, equity, inclusion, and sustainability.
• Constantly Improve: Enhance products, systems, processes, and services through innovation and calculated risk-taking.
• Are Accountable: Deliver the best work, align with core values, and take responsibility for successes and setbacks.

Compensation And Benefits

The annual pay range for this position is $102,000 - $107,000, depending on experience. Bonus eligible. Benefits information can be found here. Tolmar is an Equal Opportunity Employer.