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Quality Assurance Specialist

Quality Assurance Specialist

Katalyst Healthcares and Life SciencesJersey City, NJ, United States
20 hours 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