Regulatory & Quality Compliance Specialist

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide.

About the role

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.

Requirements

• 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.

Pay

$25.00 – $30.00 per hour

Schedule

9-month temporary assignment, onsite in Durham, NC 27703 or Morrisville, NC 27560.