Quality System Specialist (QC Compliance)

Quality System Specialist (QC Compliance)

Location : Holly Springs, NC (100% Onsite)

Job Type : Contract 12 Months

Start Date : November 3, 2025

Schedule : Monday Friday, 8 : 00 AM 5 : 00 PM

Job Overview

We are seeking a Quality System Specialist with expertise in QC compliance to provide technical leadership and support for quality processes, systems, and strategic improvements in a vaccine manufacturing environment. This role requires a strong technical understanding of QC operations, deviation investigations, change control, and quality systems including SAP, LIMS, and EDMS. The ideal candidate will demonstrate exceptional attention to detail, technical writing proficiency, and cross-functional collaboration skills.

Responsibilities

Lead deviation investigations to identify root causes and implement corrective and preventative actions (CAPAs).

Initiate and execute EDMS workflows for change control, self-inspections, and CAPA activities.

Provide support for business process systems including SAP, LIMS, EDMS, and LMS.

Manage the Work Order Tracking system to coordinate initiation, execution, and completion of work orders.

Track KPIs and project statuses; deliver presentations to cross-functional teams.

Maintain GMP documentation and ensure compliance with quality guidelines and SOPs.

Collaborate with cross-functional teams across multiple departments and CSL Seqirus sites.

Required Qualifications

2+ years of experience in vaccine manufacturing industry .

Bachelor's or Associate degree in a scientific discipline.

Proven experience with technical writing , specifically writing investigations.

Strong attention to detail with ability to interpret and follow complex instructions.

Excellent written and verbal communication skills.

Strong presentation skills for delivering updates to teams and stakeholders.

Self-motivated with excellent organizational and time management abilities.

Preferred Qualifications

Knowledge of GMP standards , safety regulations, and data integrity requirements.

Familiarity with SAP, LIMS, EDMS, and LMS systems.

Experience tracking metrics and managing compliance-related projects.

Additional Details

Interview Process : Two onsite interviews with hiring team members.

Supplier submission limit : 2 candidates per supplier.