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.