Quality and Training Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

• Summarized Purpose:
• Oversees and coordinates training and/or quality programs and activities. Schedules training for new
• employees, identifies training gaps and develops and delivers training programs and curriculums to
• promote continuous improvement. Leads or performs quality reviews of MIA and MIS staff customer
• interactions and associated documentation and coordinates and assists with corrective action plans if
• needed. Ensures program compliance with corporate, departmental and client policies and procedures
• including SOPs and applicable health authority regulations (e.g. FDA, EMEA), as well as standard inquiry
• management and documentation practices. May serve as a liaison with the clients for training or quality
• topics.
• Essential Functions and Other Job Information:
• Essential
• Functions
• •Schedules, develops and delivers training courses and content for all staff
• members. Conducts product or disease state training for staff members as
• required.
• •Monitors effectiveness of training and observes training sessions, trends and
• assesses impact in employee performance. Modifies training to increase
• beneficial outcomes.
• •Integrates training with the client while negotiating organizational differences in
• culture, management structure and staffing. Liaises with the client, department
• management and staff for all training related topics. Maintains program training
• documentation in audit-ready status.
• •Conducts call and documentation review of staff members' work and monitors
• accuracy and completeness of information provided, including clinical content.
• Ensures program consistency relative to compliance with the organization and
• client policies/procedures.
• •Evaluates quality trends across the program and provides feedback and
• suggestions to the management team. Tracks and documents Quality Events.
• Develops continuous improvement initiatives based on gaps and trends
• identified.
• •Provides support for program-related audits.
• •May assist with department projects.
• Job Complexity Works on problems of moderate scope where analysis of situations or data requires
• a review of a variety of factors.
• Job Knowledge Developing professional expertise, applies company policies and procedures to
• resolve a variety of issues.
• Supervision
• Received
• Normally receives general instructions on routine work, detailed instructions on new
• projects or assignments. Exercises judgment within defined procedures and
• practices to determine appropriate action.
• Business
• Relationships
• Contacts are primarily internal to the company with infrequent external customer /
• vendor contact on routine matters. Builds productive internal / external working
• relationships.
• Qualifications:
• Education and Experience:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
• 2+ years).
• In some cases an equivalency, consisting of a combination of appropriate education, training
• and/or directly related experience, will be considered sufficient for an individual to meet the
• requirements of the role.
• Knowledge, Skills and Abilities:
• •Strong understanding of applicable health authority (e.g. FDA, EMA) or local regulations
• •Good knowledge of drugs and drug information
• •Ability to perform call/document review, including complex clinical discussions and provide clear and
• concise feedback
• •Firm organizational and time management skills
• •Strong attention to detail and ability to multi-task
• •Strong verbal and written communication skills
• •Solid problem solving skills
• •Strong computer skills including Microsoft Office
• •Ability to train and mentor others
• •Excellent language skills (comprehension, speaking, reading and writing) must be demonstrated if the
• position requires languages other than English
• •Ability to work in a team environment and/or independently as needed
• Management Role:
• No management responsibility
• Working Conditions and Environment:
• •Work is performed in an office environment with exposure to electrical office equipment.
• •Occasional drives to site locations with occasional travel both domestic and international.
• Physical Requirements:
• •Frequently stationary for 6-8 hours per day.
• •Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements
• of the fingers, hands, and wrists.
• •Frequent mobility required.
• •Occasional crouching, stooping, bending and twisting of upper body and neck.
• •Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop
• computer with a maximum lift of 15-20 lbs.
• •Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• •Ability to communicate information and ideas so others will understand; with the ability to listen to
• and understand information and ideas presented through spoken words and sentences.
• •Frequently interacts with others to obtain or relate information to diverse groups.
• •Works independently with little guidance or reliance on oral or written instructions and plans work
• schedules to meet goals. Requires multiple periods of intense concentration.
• •Performs a wide range of variable tasks as dictated by variable demands and changing conditions
• with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• •Regular and consistent attendance.