Sr QC Trainer

Tolmar Careers•Fort Collins, CO

1d•Onsite

About The Position

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. Serves as a "Learning Administrator" for accurate assignment, recording, and documentation of training activities in the Electronic Learning Management System (ELMS). Supports 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. Contributes to and tracks completion of training metrics, efficiencies, and effective learning outcomes, taking ownership of continuous improvement. Schedules and monitors training of new employees to ensure a smooth transition into the laboratory. Performs onboarding training of all new hires, including skills verification, basic documentation, and LIMS use for reagents and instruments. Trains QC employees at all levels in a variety of lab operations processes, sample preparations, safety practices, lab techniques, and instrumentation. Mentors analysts in day-to-day testing and documentation after training to ensure they are demonstrating best practices. Observes and works with analysts to improve turnaround times. Implements knowledge checks and requalification processes to ensure learners are retaining their training. Assists analysts at all levels in troubleshooting methods or instrumentation. Ensures training modules contain subject matter that supports the use of various instruments, proper use, and best practices. Identifies areas where new training modules and CBTs would benefit the department. Ensures all new employee training documents are current and revised as required. Completes 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+. Supports and maintains up-to-date training matrices for each applicable site. Tracks and trends training as it is planned and completed. Ensures compliance with all Training Procedures and Policies and maintains change control for all training records. Provides support to department leadership with the implementation of new training systems and related continuous improvement efforts. Generates new ideas to create efficiencies and improve processes; willingly supports new ideas and process enhancements. Provides scientific recommendations to management/technical writers regarding QC procedures as applicable. Completes technical review of applicable procedures. Completes tasks on time and with minimal errors. Follows all procedures applicable to job functions to ensure high quality of work. Mentors others in the department to ensure the department maintains high standards for quality of work. Prioritizes tasks and performs job duties with minimal guidance from management. Works to complete tasks in an efficient manner and serves as a productive member of the department. Contributes 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. Responds to spills per company procedure. Maintains compliance with all Tolmar health and safety policies, as well as OSHA standards. Accountable for maintaining an atmosphere of teamwork, cordiality, and respect towards co-workers. Exhibits a positive and understanding attitude at all times. Looks at situations from all aspects. Interacts 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 resolves 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. Demonstrates leadership aptitude in technical functions. Identifies issues and possible solutions and escalates those issues and solutions to the department senior leadership or management as appropriate. Assists in quality investigations that involve training issues and works with investigators to develop and implement effective CAPAs. Reviews errors made by analysts in the lab and collaborates with department management and other leadership to create tangible improvements to processes that will prevent errors. Assists with testing, data review, and lab operations tasks to support business demand as needed. Performs additional duties as assigned.

Requirements

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.
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.

Nice To Haves

Previous experience in technical training capacity strongly preferred.

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.