Sr QC Trainer

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

Purpose and Scope

Performs training for QC employees on quality control processes and test methods for raw materials, cleaning samples, bulk intermediate and finished product, and/or stability samples, according to established regulatory protocols and company procedures.

Essential Duties & Responsibilities

• Serve as “Learning Administrator” for accurate assignment, recording and documentation of training activities in the Electronic Learning Management System (ELMS).
• Support Subject Matter Experts (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 on boarding 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.
• Assist analysts at all levels in troubleshooting methods or instrumentation.
• Ensure training modules contain subject matter that supports the use of various instruments proper use and best practices.
• 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 maintains 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 review 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 performs 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.
• Participates in required monthly safety trainings and annual HAZ-COM, 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.
• 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.
• High level experience in the use of USP, NF and other compendia.
• Demonstrated learning agility and ability to translate effectively to others.
• Demonstrate high level of proficiency in training delivery.
• 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.
• Effective written and oral communication skills.
• Well versed in all types of laboratory instrumentation.
• Ability to interpret, understand and follow advanced analytical procedures and calculations.

Core Values

• The Senior QC Trainer is expected to operate within the framework of Tolmar’s Core Values:
• Center on People: We commit to support the well-being of our patients and treat 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 with an enterprise-wide mindset that lifts the whole organization.
• 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 proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk-taking that drives better ways of working.
• 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, 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.

Working Conditions

• Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.
• 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 across multiple shifts and locations.

Compensation and Benefits

• Annual pay range $102,000 - $107,000 depending on experience
• Bonus Eligible
• 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.