Back to jobs

TrackWise Consultant

Non-Headquarters

Valpro has several available opportunities supporting our world-class client sites or partner organizations.  Whether you are an independent consultant or a potential employee looking for your next project, learn more about what we have to offer. View our open positions below.

TrackWise Consultant – Change Control

Location: Raleigh–Durham, NC

Job Summary:

We are seeking an experienced TrackWise Consultant specializing in Change Control to support on-site operations within a life sciences organization in the Raleigh–Durham, NC area. This role requires a strong on-site presence and close collaboration with Quality, Manufacturing, Validation, and IT teams in a GxP-regulated environment. The consultant will lead and support TrackWise Change Control activities to ensure regulatory compliance, operational efficiency, and continuous improvement.

Key Responsibilities:

  • Act as the on-site TrackWise Subject Matter Expert (SME) for Change Control processes.
  • Configure, administer, and support TrackWise Change Control workflows, forms, business rules, and user roles.
  • Manage the end-to-end Change Control lifecycle, including initiation, impact assessment, risk evaluation, approvals, implementation oversight, and closure.
  • Partner closely with on-site Quality, Manufacturing, Engineering, Validation, and IT stakeholders to assess and implement changes in compliance with GMP and FDA requirements.
  • Support and execute Computer System Validation (CSV) activities for TrackWise, including risk assessments, test script development, execution, and traceability.
  • Author, review, and maintain quality documentation such as SOPs, work instructions, configuration specifications, and validation deliverables.
  • Provide on-site user support and training, including troubleshooting system and process-related issues.
  • Support internal and external audits and regulatory inspections by providing Change Control documentation, system demonstrations, and SME support.
  • Drive continuous improvement initiatives for Change Control processes and system usability.

Qualifications:

  • Bachelor’s degree in engineering, Life Sciences, Information Technology, or a related discipline.
  • 5+ years of hands-on experience with TrackWise in a GxP-regulated life sciences environment.
  • Strong expertise in Change Control processes and electronic Quality Management Systems (eQMS).
  • Working knowledge of FDA and global regulations, including 21 CFR Parts 210, 211, and 11.
  • Proven experience supporting CSV for quality systems.
  • Ability to work full-time on-site and collaborate directly with cross-functional teams.
  • Strong communication, documentation, and stakeholder management skills.

 

Apply now to be part of a high-visibility engagement where your TrackWise expertise truly matters!

 

Valpro offers flexible career options that includes benefits such as paid time off, paid holidays, medical, 401K match, and other unique incentives.

When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net.  Any other domains are impersonations and should be ignored.

Candidates must be legally eligible to work in the United States without company sponsorship.  Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valpro. Valpro will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valpro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

Create a Job Alert

Interested in building your career at Valpro? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...

U.S. Citizens should select No to this question. Please select Yes or No to designate whether you require sponsorship to work for any U.S. employer, now or in the future.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Valpro’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.