GxP Senior Training Specialist

Position Summary

The Sr. Training Specialist reports to Senior Manager of Quality Systems or above and is responsible for supporting the implementation and execution of corporate quality training programs related to key compliance initiatives, applicable regulatory requirements, local and global processes and for the continuous improvement of compliance across Minaris facilities.

Essential Functions And Responsibilities

• Track, trend and monitor training curriculum compliance

• Manage site GxP training program(s) to ensure compliance with federal, state and local regulations

• Instill continuous improvement related to training materials, programs and processes

• Partner with site technical training representatives and SMEs from other disciplines to create, implement and harmonize processes and procedures

• Support the Minaris Continuing Education system by providing support for continued improvement

• Support audit requests for training reports, as needed

• Support Global Head, Director of Quality Systems, L&D on all facets of GxP Training LMS Administration

• Lead Administrator supports and maintains the GxP Compliance training system for employee and external resources

• Manage general training curriculum for all Minaris personnel that ensures compliant GxP practices

• Maintain LMS report management, inclusive of creation, addition, and editing for the customer, business, and audits/inspections

• Tracks all LMS updates/release information

• Facilitate learning experiences in multiple delivery modalities including, but not limited to, eLearning, instructor-led training in both in person and virtual environments

• Manage and review content development requests; such as presentations and computer-based training for business value and project prioritization

• Evaluate training needs and develop eLearning solutions through the application and utilization of various adult learning principles and eLearning technology tools

• Perform other duties as assigned

Knowledge, Skill & Ability

• Ability to accomplish the described duties through the use of appropriate computer equipment and software (Veeva, Microsoft Word, Excel, Outlook, and Access)

• Ability to record data accurately and legibly

• Ability to use judgment as dictated by the complexity of the situation

• Ability to understand and follow verbal or demonstrated instructions

• Ability to work effectively as part of a team and to exhibit effective interpersonal skills

• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication

• Proficient in Oral & Written communication skills

Education & Experience

• 3-5 years of relevant experience or equivalent

• Bachelor’s degree or equivalent experience

• Strong knowledge and application of adult learning theory and instructional design principles with a strong focus on eLearning/virtual design/graphic design and training methodologies, utilizing the latest interactive learning technologies

• Strong working knowledge of various authoring and eLearning development tools; i.e., Articulate Storyline, Adobe Captivate, Adobe Connect, PhotoShop, Adobe Illustrator, Adobe After Effects, and/or Adobe Premiere

• Strong working knowledge of recording and editing audio and using eLearning development tools

• Ability to author, edit and review Standard Operating Procedures

• Self-motivated and able to work efficiently with minimal supervision

• Excellent communication skills, ability to work in a diverse, multi-cultural environment, detail oriented, willingness to “roll up sleeves” and do the work required for success

Quality Requirements

• Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work

• Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence

Working Environment

• This is an onsite Position

• Onsite Employees: Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight.

• The work environment is fast paced.

• This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct.

• Off-shift, weekend and overtime duties may be required.

Special Working Conditions

• May be required to assist in other departments

• May be required to work weekends or holidays

• May be required to travel to other Minaris sites for training support

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.

Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.