Regulatory & Quality Compliance Specialist

Position: Regulatory & Quality Compliance Specialist

Location: Durham, NC 27703

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: Monday to Friday from 08:00 AM – 05:00 PM with some flexibility

Pay Rate: $25 to $30

Note: Candidates have an option to pick to work from either Durham, NC 27703/ Morrisville, NC 27560.

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.

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.