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Technical and Craft Labor Quality Specialist II
Job Location:
Job Location:
Durham, NC - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
27 May 2026 (30+ days ago)
Posted:
Application Deadline:
24 August 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Regulatory & Quality Compliance Specialist (Temporary 3 to 6 Months) - Onsite
Location: 3900 Paramount Parkway South Building Morrisville North Carolina or 4063 Stirrup Creek Drive Durham North Carolina
How you will make an impact
This role will provide critical short-term support to ensure continuity of Regulatory and Quality compliance operations. By executing high-volume detail-oriented tasks across product regulatory processes and the PCS Quality Management System (QMS) you will help maintain data integrity support inspection readiness and reduce operational backlog. Your contributions will directly enable compliant product commercialization and strengthen audit readiness.
What you will do
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 ensuring accuracy and completeness of product data.
- Review product opportunities and cases for compliance risks and escalate as needed.
- Partner cross-functionally to resolve discrepancies and ensure timely product readiness.
SDS & Documentation Management
- Manage Safety Data Sheet (SDS) documentation in ebinder including upload revision control and archival.
- Ensure SDS records are current compliant and audit-ready.
- Support remediation of SDS documentation gaps and backlog.
Regulatory Reporting
- Support California controlled substance reporting activities.
- Prepare and submit monthly controlled substance and ethanol reports.
- Validate data accuracy and maintain inspection-ready records.
Quality Management System (TrackWise)
Internal & Customer Audits
- Coordinate internal audit scheduling including auditor assignment and tracking.
- Maintain audit records in TrackWise and follow up on open items.
- Support customer audit preparation and documentation.
Quality Events & Complaints
- Review complaint records for completeness and compliance.
- Support processing of deviations and CAPAs within TrackWise.
- Escalate incomplete or non-compliant records.
Additional Department Support
- Provide support for backlog reduction record updates and inspection readiness initiatives.
- Support sampling services at the PCS Durham warehouse location as needed
- Additional duties may be assigned by manager
Keys to Success
- Deliver accurate timely completion of regulatory and quality system tasks.
- Reduce backlog across SDS and QMS records.
- Maintain audit-ready documentation across systems (Aplus ebinder TrackWise).
- Effectively coordinate audit activities and reporting deliverables.
Minimum Requirements
- Bachelor s degree in a scientific or related field preferred.
- 2 years of experience in a regulated environment.
- Experience with QMS tools such as TrackWise preferred.
Knowledge Skills Abilities
- Strong attention to detail and commitment to data integrity.
- Ability to execute high-volume tasks with accuracy and efficiency.
- Familiarity with GMP and regulatory requirements.
- Strong organizational and collaboration skills.
Work Environment
- Onsite role based in North Carolina.
- Temporary assignment (3 6 months) focused on immediate business impact.
- Requires ability to quickly learn systems and contribute with minimal ramp-up. Project Code :
Location: 3900 Paramount Parkway South Building Morrisville North Carolina or 4063 Stirrup Creek Drive Durham North Carolina
How you will make an impact
This role will provide critical short-term support to ensure continuity of Regulatory and Quality compliance operations. By executing high-volume detail-oriented tasks across product regulatory processes and the PCS Quality Management System (QMS) you will help maintain data integrity support inspection readiness and reduce operational backlog. Your contributions will directly enable compliant product commercialization and strengthen audit readiness.
What you will do
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 ensuring accuracy and completeness of product data.
- Review product opportunities and cases for compliance risks and escalate as needed.
- Partner cross-functionally to resolve discrepancies and ensure timely product readiness.
SDS & Documentation Management
- Manage Safety Data Sheet (SDS) documentation in ebinder including upload revision control and archival.
- Ensure SDS records are current compliant and audit-ready.
- Support remediation of SDS documentation gaps and backlog.
Regulatory Reporting
- Support California controlled substance reporting activities.
- Prepare and submit monthly controlled substance and ethanol reports.
- Validate data accuracy and maintain inspection-ready records.
Quality Management System (TrackWise)
Internal & Customer Audits
- Coordinate internal audit scheduling including auditor assignment and tracking.
- Maintain audit records in TrackWise and follow up on open items.
- Support customer audit preparation and documentation.
Quality Events & Complaints
- Review complaint records for completeness and compliance.
- Support processing of deviations and CAPAs within TrackWise.
- Escalate incomplete or non-compliant records.
Additional Department Support
- Provide support for backlog reduction record updates and inspection readiness initiatives.
- Support sampling services at the PCS Durham warehouse location as needed
- Additional duties may be assigned by manager
Keys to Success
- Deliver accurate timely completion of regulatory and quality system tasks.
- Reduce backlog across SDS and QMS records.
- Maintain audit-ready documentation across systems (Aplus ebinder TrackWise).
- Effectively coordinate audit activities and reporting deliverables.
Minimum Requirements
- Bachelor s degree in a scientific or related field preferred.
- 2 years of experience in a regulated environment.
- Experience with QMS tools such as TrackWise preferred.
Knowledge Skills Abilities
- Strong attention to detail and commitment to data integrity.
- Ability to execute high-volume tasks with accuracy and efficiency.
- Familiarity with GMP and regulatory requirements.
- Strong organizational and collaboration skills.
Work Environment
- Onsite role based in North Carolina.
- Temporary assignment (3 6 months) focused on immediate business impact.
- Requires ability to quickly learn systems and contribute with minimal ramp-up. Project Code :
