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Trackwise Jobs (NOW HIRING)

Enter document reviews into Trackwise and maintain up-to-date and accurate Excel documentation. * Support the verification process of all patient records, ensuring completeness, accuracy, and ...

Experience using Trackwise software for tracking of quality system records. 4 year degree required Experience working with cross functional teams to identify and address quality issue root causes.

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How much do trackwise jobs pay per month?

As of Aug 18, 2026, the average monthly pay for trackwise in the United States is $8,731.92, according to ZipRecruiter salary data. Most workers in this role earn between $5,208.33 and $12,250.00 per month, depending on experience, location, and employer.

What is a Trackwise?

A TrackWise job typically involves working with TrackWise, a quality management system (QMS) used in regulated industries like pharmaceuticals, medical devices, and biotechnology. Professionals in these roles manage and configure TrackWise to streamline quality processes such as deviations, CAPA, audits, and complaints. Responsibilities may include system administration, troubleshooting, validation, and ensuring compliance with regulatory standards. Strong knowledge of TrackWise configuration, workflows, and reporting is often required.

What does a Trackwise specialist do?

As a TrackWise Specialist, your typical day involves configuring and maintaining the TrackWise quality management system, resolving user issues, and supporting key functions such as CAPA, document management, and audit tracking. You will regularly collaborate with quality assurance, IT, and operations teams to ensure system alignment with company processes and regulatory requirements. Additionally, you may train end-users, generate reports, and participate in system upgrades or process improvement initiatives. This role requires strong attention to detail and excellent communication skills to ensure accurate data management and continuous quality improvement.

What are the key skills and qualifications needed to thrive in the Trackwise position?

To thrive as a TrackWise Specialist, you need a strong foundation in quality management systems (QMS), regulatory compliance knowledge, and experience in data analysis, typically supported by a degree in life sciences, engineering, or a related field. Proficiency in the TrackWise QMS software, as well as familiarity with document control, CAPA, and audit management modules, is essential, and TrackWise certification is highly regarded. Strong problem-solving, attention to detail, and effective communication skills are key soft skills for collaborating with cross-functional teams and troubleshooting system issues. These competencies are critical to maintaining regulatory compliance, optimizing workflow efficiency, and ensuring the successful implementation and support of TrackWise solutions in an organization.

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Infographic showing various Trackwise job openings in the United States as of August 2026, with employment types broken down into 89% Full Time, 10% Contract, and 1% Nights. Highlights an 94% Physical, 3% Hybrid, and 3% Remote job distribution, with an average salary of $104,783 per year, or $50.4 per hour.

Regulatory & Quality Compliance Specialist

TekWissen LLC

Morrisville, NC • On-site

Temporary

Re-posted 23 days ago


Job description

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.

Position:       Regulatory & Quality Compliance Specialist
Location:     Durham, NC 27703/ Morrisville, NC 27560
Duration:     6 Months
Job Type:     Temporary Assignment
Work Type: Onsite
Shift:            Monday to Friday from 08:00 AM – 05:00 PM with some flexibility

Summary:

The Regulatory & Quality Compliance Specialist will provide critical short-term support to ensure continuity of regulatory and quality compliance operations. This role focuses on regulatory reviews, product data management, audit coordination, SDS documentation management, and Quality Management System (QMS) support. The ideal candidate will have experience in regulated environments, strong attention to detail, and the ability to manage high-volume compliance tasks efficiently.

Responsibilities:

Regulatory Operations & Product Data
  • Perform product regulatory reviews to support compliant commercialization in U.S. and EU markets.
  • Execute SKU setup and maintenance in Aplus systems with accuracy and completeness.
  • Review SF.com product opportunities and cases for compliance risks and escalate issues as needed.
  • Collaborate cross-functionally to resolve discrepancies and support product readiness.
SDS & Documentation Management
  • Manage Safety Data Sheet (SDS) documentation in ebinder systems.
  • Handle upload, revision control, archival, and remediation of SDS records.
  • Ensure documentation remains current, compliant, and audit-ready.
Regulatory Reporting
  • Support California controlled substance reporting activities.
  • Prepare and submit monthly controlled substance and ethanol reports.
  • Validate data accuracy and maintain inspection-ready documentation.
Quality Management System (TrackWise)
  • Coordinate internal audit scheduling and auditor assignments.
  • Maintain audit records and track open items within TrackWise.
  • Support customer audit preparation and required documentation activities.
Quality Events & Complaints
  • Review complaint records for completeness and compliance.
  • Support deviations and CAPA processing within TrackWise.
  • Escalate incomplete or non-compliant records appropriately.
Additional Support
  • Assist with backlog reduction and inspection readiness initiatives.
  • Support sampling services at the PCS Durham warehouse location as needed.
  • Perform additional duties assigned by management.

Required Skills:

  • Bachelor’s degree in a scientific or related field preferred.
  • Minimum of 2 years of experience in a regulated environment.
  • Experience with QMS platforms such as TrackWise preferred.
  • Familiarity with GMP and regulatory compliance requirements.
  • Strong attention to detail and commitment to data integrity.
  • Ability to manage high-volume tasks with accuracy and efficiency.
  • Strong organizational, communication, and collaboration skills.
  • Ability to quickly learn systems and contribute with minimal ramp-up time.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.


TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.

Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.

TekWissen® is an equal opportunity employer supporting workplace diversity. 


TekWissen logo

About TekWissen

Sourced by ZipRecruiter

TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.

Industry

Recruiting and staffing services

Company size

501 - 1,000 Employees

Headquarters location

Ann Arbor, MI, US

Year founded

2009

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