Katalyst Healthcares and Life SciencesJersey City, NJ, United States
8 days ago
Job type
Full-time
Job description
Job Description :
We are recruiting for a detail-oriented and highly organized QA Specialist to join our team in a remote, contract role to support our External Supply Quality (ESQ) team.
The QA Specialist will assist the External Supply Quality (ESQ) team by managing documentation, system entries and administrative tasks.
This role focuses on maintaining accurate records, supporting document control and ensuring quality-related processes remain compliant and organized. The position does not require technical decision-making but provides critical support to help ESQ meet compliance and operational goals.
This role is essential in ensuring that internal quality documentation, records, and systems are accurately maintained and compliant with regulatory and internal standards.
The QA Specialist will focus on document control, administrative tasks, and quality system support - enabling the ESQ team to achieve compliance and operational goals efficiently.
This position is ideal for individuals with strong documentation, organization, and quality system experience who thrive in a collaborative, compliance-driven environment.
This position is focused on internal documentation and system support only; no supplier-facing responsibilities are required.
Responsibilities :
Document Management : Upload, route, and track controlled documents in Quality Management Systems (QMS), including experience with platforms such as Veeva (preferred).
System Support : Enter and manage data in internal systems, generate routine reports, maintain trackers, and assist in preparing quality metrics.
dministrative Support : Provide ongoing administrative assistance to the ESQ team including scheduling, file maintenance, and workflow tracking.
Document Control : Proofread, format, and manage quality documentation to ensure consistency, compliance, and audit-readiness.
udit Readiness : Organize records and documentation to support inspections, internal audits, and QA reviews.
Collaboration : Work closely with cross-functional internal teams, ensuring timely coordination and follow-through on quality system deliverables.
Compliance Support : Ensure all documentation and processes adhere to internal quality standards and regulatory requirements.
Requirements :
Experience : 7+ years in a Quality Assurance or document control role, in a regulated environment (pharmaceutical, biotech, or medical device industries).
Document Management Expertise : Proficient in managing controlled documents within QMS platforms; Veeva experience is a strong plus.
Technical Skills : Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), SharePoint, Smartsheet, and other electronic workflow tools.
ttention to Detail : Strong proofreading, formatting, and record-keeping skills.
Organizational Abilities : Excellent time management and the ability to prioritize multiple tasks and deadlines.
Data Handling : Comfortable compiling reports, maintaining tracking tools, and working with metrics.
Communication : Clear and professional written and verbal communication skills.
Team Player : Demonstrated ability to work effectively in a team environment and support cross-functional stakeholders.
Degree : Bachelor's degree preferred, or equivalent administrative / documentation experience in a regulated environment.
7+ years of work experience with Data Management.
7+ years of work experience with Quality Assurance.
3+ years of work experience with Veeva.
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Quality Assurance Specialist • Jersey City, NJ, United States
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