What are the responsibilities and job description for the Quality Assurance Specialist position at Katalyst Healthcares & Life Sciences?
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.
- 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.
- Administrative 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.
- Audit 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.
- 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.
- Attention 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.
