Responsible for the design, development and implementation of site-wide training. Develop, plan, schedule, deliver and document orientation agendas for new employees in concert with HR and Operational staff. Train new and existing staff in routine to advanced level laboratory techniques and other staff development programs to maintain and improve performance and quality across the site. Investigate, develop, revise, and implement training tools to include SOPs and processes to support the overall training program. Ensure that new and existing lab personnel are proficient in skill sets required to perform in a cGMP laboratory work group.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Develop training materials and coordinate and deliver training for new and active employees in areas such as basic through advanced level laboratory skills, use and interpretation of SOP’s, cGMP topics (good documentation, root cause analysis, investigations), specific departmental procedures, use and interpretation of protocols, safety and health issues and technical, administrative and other site processes and procedures.
•Develop and maintain the On Boarding Program for site staff and coordinate and provide technical and other types of training for new employees.
•Provide technical training support to all areas of laboratory operations and develop and manage core competency goals and achievements for personnel.
•Re-certify current employees as needed in various techniques and review their technical progress to ensure they meet minimum proficiency standards. Provide and coordinate additional training to personnel based on identified trends, gaps and noted deficiencies.
•Ensure employees are trained in the use and requirements of Personal Protective Equipment (PPE).
•Ensure that all training is documented and training records are maintained in a timely manner and in compliance with SOPs and cGMP requirements.
•Provide quality review for training records; provide summary of review findings to appropriate departments’ personnel and recommend actions and implement changes as needed.
•Draft, review, and revise training documentation to ensure that all procedures are in agreement with SOPs and meet quality and current regulatory requirements.
•Engage in long term improvement projects which may include the redesign of BRs, SOPs, qualification protocols and validation procedures to promote harmonization of effective processes.
•Assist with drafting responses and CAPA solutions for responses for internal and external client and regulatory audit observations pertaining to training.
•Ensure that qualified personnel are selected to augment training events and that orientation and on-the-job training programs are conducted in a timely manner and assess effectiveness.
•Collaborate with Department management, cross-site personnel and internal/external resources to develop and implement new training and improve the overall training program. Assist departments in identifying cross-training opportunities.
•Provide prompt and objective coaching and mentor staff with the goal of developing and improving their overall technical abilities.
•Ensure optimum performance of function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities and maintain state-of-the-art practices.
•Assist in development of and adequate plan for backup and succession of key personnel in target work groups.
•Keep abreast of current trends and practices in field of expertise.
•Deliver other, non-technical, training programs to employees as assigned.
•Act within scope of authority and be consistent with company and corporate objectives, guidelines, policies and practices.
•Perform all other duties as assigned.Qualifications
•Education: Bachelor’s degree (B.A./BS.) in a scientific discipline. Master’s degree in scientific/teaching discipline preferred.
•Experience: 5-7 years related experience in a cGMP laboratory facility (pharmaceutical or biotech) environment.
•An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•Other: Proficiency with MS Office applications and the ability to learn and use various software packages. In-depth understanding of regulations and GMPs/SOPs. Effective written and verbal communication skills. Ability to multitask, prioritize and meet deadlines. Must be able to effectively perform public speaking and utilize effective training principles.
•Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
•Must regularly communicate with employees/customers; must be able to exchange accurate information.
•Must occasionally move about inside the office to access file cabinets, office machinery, etc.
•Both general office and laboratory working conditions.
•The noise level in the work environment is usually moderate.
•Must be able to regularly wear protective clothing and equipment, such as eye wear, surgical mask, cap, scrubs, boots, and respirator).
•Regularly works with sharp objects. Regularly works with or near toxic or caustic chemicals.
•May occasionally work on weekends or holiday
•This position requires occasional domestic travel.
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet