QC Compliance
QC Compliance
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Salary Not Disclosed
1 Vacancy
Job Description
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
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).
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Initiate and execute EDMS workflows for change control self-inspections and CAPA activities.
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Provide support for business process systems including SAP LIMS EDMS and LMS.
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Manage the Work Order Tracking system to coordinate initiation execution and completion of work orders.
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Track KPIs and project statuses; deliver presentations to cross-functional teams.
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Maintain GMP documentation and ensure compliance with quality guidelines and SOPs.
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Collaborate with cross-functional teams across multiple departments and CSL Seqirus sites.
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2 years of experience in vaccine manufacturing industry.
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Bachelors or Associate degree in a scientific discipline.
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Proven experience with technical writing specifically writing investigations.
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Strong attention to detail with ability to interpret and follow complex instructions.
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Excellent written and verbal communication skills.
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Strong presentation skills for delivering updates to teams and stakeholders.
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Self-motivated with excellent organizational and time management abilities.
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Knowledge of GMP standards safety regulations and data integrity requirements.
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Familiarity with SAP LIMS EDMS and LMS systems.
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Experience tracking metrics and managing compliance-related projects.
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Interview Process: Two onsite interviews with hiring team members.
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Supplier submission limit: 2 candidates per supplier.
Employment Type
Full Time
