Validation and Quality Systems Industry Trainer

Validation and Quality Systems Industry Trainer


Wake Technical Community College
9101 Fayetteville Road
Raleigh, NC 27603
Phone: 919-866-5000

Job Location

BioNetwork Capstone Center


$58,462.53 - $77,482.00


State of NC

Job Category

  • Professional

Application Period

Opens: Thursday, November 19, 2020
Closes: Thursday, December 31, 2020

Target Start Date

Monday, January 4, 2021

Expected Work Hours

Hour may vary

Employment Type

Full-time Annual

Minimum Qualifications

Master's degree preferably in a life science, chemistry, regulatory science, biopharmaceutical sciences or related field

Ten years of experience  working in a cGMP regulated,  medical product (pharmaceutical, medical devices, biologics)  manufacturing environment within either a validation or quality assurance capacity 

Ability to travel 20% annually

Valid Driver's License

Preferred Qualifications

Fifteen years preferred working in a cGMP regulated,  medical product (pharmaceutical, medical devices, biologics)  manufacturing environment within either a validation or quality assurance capacity 

Experience supervising a team

Experience functioning in a leadership role while performing project execution

Experience in creating and delivering training programs within community college environment

Essential Personnel:


Position Description

Pay Grade: Professional 8

The Industry Trainer, Validation and Quality Systems develops courses and training programs for clients including customized training departments within the NCCCS, biotech companies from across the state of North Carolina, NC universities and colleges, the Food and Drug Administration (FDA), and international bio manufacturing companies.

This position is part of a state-wide Bionetwork program funded by the North Carolina Community College System.  Wake Technical Community College serves as the fiscal agent for this position.  Daily operational and supervisory activities are conducted and managed by North Carolina Community College System personnel. 

Most postings are open for a limited time, depending upon the number of applications received. When the stated closing date is "Continuous", please apply immediately. The position may close without notice.

 Responsibilities and Duties (*Essential Functions):

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily.  Reasonable accommodations may be made to enable individuals with disabilities to perform the primary job functions herein described.  

*Develop new lecture material and course modules including course syllabi, presentation slides, team activities  and assessments catered to college, company and student needs

*Deliver hands-on, industry specific workforce development courses to customers as a Subject Matter Expert (SME) in Validation and Quality Systems such as Current Good Manufacturing Practices for Pharmaceuticals and Medical Devices, Fundamentals of Validation, Good Documentation Practices for Pharmaceuticals and Medical Devices , and ensure training meets best practices according to current OSHA, Food and Drug Administration (FDA), ISO and European Union (EU) regulations, and USP, WHO, ISPE and PDA Guidance
*Oversees adjunct industry trainers to include hiring supervision, assignments, scheduling, coordinating training activities, goal setting, and evaluations

*Statewide responsibility to work with Customized Training Directors (CTDs) and their respective community colleges to determine industry training needs and execute course delivery

Research, design and develop class and laboratory activities relevant for assigned courses on processes related to manufacturing of medical products such as quality systems and validation.

Develop the Validation Academy Certificate Program

Works with management and cross-functional teams to strategically plan a training roadmap of future training and development needs and participates in meetings and committees with industry clients and other stakeholders 

Maintains effective working relationships with industry representatives, BioNetwork colleagues, community college staff and the general public

Serves as a representative of BioNetwork to promote the Validation Academy at industry related conferences and meetings, biomanufacturing forums and advisory boards

Promotes continuous improvement by completing an annual applied benchmark project on an individual or a group basis


Knowledge, Skills & Abilities:
Exceptional written and oral communication skills
Exceptional organizational and time management skills; ability to multi-task with demonstrated commitment to follow-through expeditiously
Strong interpersonal and leadership skills
Ability to work effectively both independently and in a team environment
Knowledge of principles and methods for curriculum and training design, teaching, and instruction for individuals and groups and the measurement of learning transfer
Ability to select training/instructional methods and procedures appropriate for the intended audience
Ability to analyze and interpret regulatory guidelines
Ability to use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems

Proficiency in Microsoft Office and the use of internet resources

Willingness to learn and expand knowledge base

How to Apply

Interested applicants may submit an application to this link: Validation and Quality Systems Industry Trainer

Job Post Contact

Human Resources