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Analytical Development Trainer II

TOLMAR Pharmaceuticals

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$43.27-44.23 /h
PAY RATE
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Fort Collins, CO
LOCATION

Job Description

As posted by the hiring company

Job Overview:

Purpose and Scope

 Responsible for the training program in the Analytical Development department, including developing, coordinating, or administering training, by following cGMP and regulatory requirements. Primary focus is assessing and developing training needs in the analytical R&D area and collaborating with SMEs to develop and deliver training to meet those needs. This includes onboarding training, basic and advanced laboratory skills, tracking and training progression of new hires, and existing staff skill enhancement training.

Essential Duties & Responsibilities

  • Ensures efficient, effective, and rapid introduction of new analysts into the analytical development department. Acts as a primary resource to introduce new analytical chemists' values, cultural and behavioral expectations.
  • Deliver in-person training to staff as appropriate. Work with individuals, subject matter experts (SMEs), instrument and software administrators, and management to establish and improve training documents for analytical instrumentation, laboratory techniques, methods, and method development.
  • Identify and implement improved training methods to increase employee effectiveness, including developing or enhancing in-house programs and practices to identify developmental needs for personnel growth and efficiencies.
  • Schedule, deliver and monitor laboratory and department onboarding training to all new hires, including hands-on laboratory skills verification, basic documentation, and systems used in the department and company.
  • Functions as a mentor on good laboratory practices, good documentation practices and department procedures to the analytical development department.
  • Collaborate with the EHS group to ensure safe laboratory practices and incorporate all relevant safety information. Review incident reports related to laboratory practices and work with EHS to identify potential gaps or contributing factors to strengthen training programs.
  • Develop and perform refresher training as needed. Work with management and other stakeholders to determine and implement expected timelines for the performance of refresher training.
  • Contribute to and support department leadership with implementing new training systems, training metrics, effective learning outcomes, and related continuous improvement efforts. Generate new ideas and recommendations to create efficiencies and improve processes; willingly support new ideas and process enhancements.
  • Schedule and assist with internal and external training courses.
  • Ensure compliance with all company training procedures and policies, and ensure all employee-training documents are current and revised and completed as required. Accountable for documenting all training and refresher activities and maintaining records according to good documentation practices and ALCOA+.
  • Department liaison for all training activities, coordinates and assists the Learning and Development department to organize and ensure accessibility of historical training records for the R&D teams.
  • Serve as "Learning Administrator" to create training plans, curricula and run reports while maintaining regulatory compliance. Maintain and execute change control actions for all training activities.
  • Manage the laboratory notebooks request and assignment process, periodic inventory and audit of notebooks, and submission of notebooks for archiving according to company procedures and regulatory requirements.
  • As applicable, provide scientific recommendations to management, technical writers, or data review procedures.
  • Participates in required monthly safety training and annual HAZ-COM, RCRA and API handling training. 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 with all Tolmar health and safety policies, as well as OSHA standards.
  • Interact respectfully with all employees both inside and outside of the department and members of management. Show interest in others' input and reasoning and appropriately resolve differences of opinion.
  • Perform additional duties as assigned.

Knowledge, Skills & Abilities

  • Demonstrated experience and proficiency in laboratory techniques, including sample preparation in various matrices, integration and calculation of results, interpretation of data from multiple laboratory instruments, and laboratory safety.
  • Participates in related site activities, such as troubleshooting and analytical problem-solving, while incorporating any learnings or changes to the training program.
  • Well-versed in commonly used laboratory instrumentation, including HPLC, GC, Dissolution etc.
  • Demonstrated aptitude and proficiency in training and mentoring others in laboratory practices and techniques, documentation requirements, and regulations according to GXP and GSP.
  • Competent in government regulations for drugs or medical devices, including GMP, GLP and ICH and their application to laboratory testing, review processes, and procedures.
  • Proficient with training and mentoring junior analysts.
  • Ability to interpret, understand and follow advanced analytical procedures and calculations.
  • Effective written and oral communication skills.

 

Core Values

  • The AD Trainer II is expected to operate within the framework of Tolmar's Core Values:
    • Consistently operate with the highest standards of ethics and compliance.
    • Take ownership of your actions, success and setbacks.
    • Respect each other and understand that honest collaboration is at the heart of our company success.
    • Go the extra mile to make things happen.
    • Be committed to all we do and the patients we serve.
    • Embrace change with enthusiasm.
    • Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

 Education & Experience

  • Doctorate or master's degree in chemistry with 5 years' of related experience; or BS degree with 8 years of related laboratory based experience; or equivalent combination of education and experience.
  • Previous experience in technical training or mentoring capacity strongly preferred.

Compensation and 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.

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.