BioNetwork Industry Trainer: Validation and Quality Systems

BioNetwork Industry Trainer: Validation and Quality Systems

Employer

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

Job Location

BioNetwork Capstone Center

Raleigh NC

Salary/Grade

$65,000-$75,600

Benefits

State of NC

Job Category

  • Professional

Application Period

Opens: Monday, December 4, 2017
Closes: Wednesday, January 31, 2018

Target Start Date

Thursday, February 1, 2018

Expected Work Hours

Varies as position demands

Employment Type

Full Time

Minimum Qualifications

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

Minimum Requirements:

Bachelor's degree preferably in a life science, chemistry, regulatory science, or related program and Eight years of experience working in a cGMP regulated, pharmaceutical manufacturing environment within either a validation or quality assurance capacity

 

OR Master's degree preferably in a life science, chemistry, regulatory science, or related program and Five years of experience working in a cGMP regulated, pharmaceutical manufacturing environment within either a validation or quality assurance capacity

Valid Driver's License

Preferred Qualifications

Preferences:

Master's degree in a life science, chemistry, regulatory science or related program

Experience supervising a team

Experience functioning in a leadership role while performing project execution

Experience in creating and delivering training programs

Ten+ years of experience working in a cGMP-regulated, pharmaceutical manufacturing environment within either a validation or quality assurance capacity
 

Position Description

This position will be responsible for developing and delivering training in assigned areas.

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. 

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.  

 

*Delivers training both on-site at the BioNetwork Capstone Center and off-site across North Carolina

*Develops short courses and training modules in pharmaceutical processing areas of expertise with an emphasis on qualification of facilities, aseptic processes, and product/process validation according to current regulatory and industry standards

*Develops short courses and training modules in  processing areas of expertise with an emphasis on risk management, sterility by design, troubleshooting and solving sterility failure  issues, investigations including  CAPA's and how to effectively implement change control within current regulatory and industry standards

Administers the Validation Academy

Monitors industry trends and benchmark practices in other states and countries

Maintains currency in field of expertise, in training and instructional development, and in course delivery to ensure best practices in designing and delivering education and training

Develops reports related to established metrics that assess the effectiveness of our programs and to gauge the needs of the industry sector

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

Represents BioNetwork at meetings, conferences and presentations by the promotion of our resources, capabilities, and programs to internal and external customers

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

Job Post Contact

Human Resources

humanresources@waketech.edu

919-866-7890