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Resilience · 2 weeks ago

Specialist II, Quality Systems

East Norriton, PA

Full-time

Onsite

Entry, Mid Level

$65K/yr - $88K/yr

2+ years exp

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. The Specialist II, Quality Systems role is responsible for developing and maintaining a compliant GMP quality management program, overseeing various quality systems and supporting audits and training activities.

BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical

No H1B

Responsibilities

Administer, maintain, and improve core quality systems such as Document Management System, Learning Management Systems, and Quality Management Systems

Review, route, and manage controlled documents, SOPs, Forms, throughout their lifecycle

Assist with document disposition activities and act as site Business Process Owner (BPO), as needed

Author and review technical documents including but not limited to SOPs, various quality reports

Support internal audits, client audits, and regulatory inspections

Support additional Quality initiatives both inner and interdepartmentally, as needed

Support onboarding of new employees across the site

Assist with training activities and act as site Business Process Owner (BPO), as needed

Manage and execute quality system processes including procedures, validation, deviation management, change control, CAPAs, etc

Maintain and organize the controlled document archive, ensuring timely filing, version control, and secure retention in compliance with cGMP, regulatory, and internal quality system requirements

Qualification

GMP Quality ManagementQuality Systems SoftwareGxP Regulatory KnowledgeQuality Records ManagementComputer Systems ValidationMicrosoft 365Customer ServiceCommunication