Quality Assurance Specialist
1 month ago
6 month contract - covering for a maternity leave
SSF - onsite 5 days per week
$40 - $50 per hr
Responsibilities
- Perform daily operations of Quality Systems (Veeva Vault) and Document Control functions to ensure compliance with regulatory and Nkarta requirements.
- Support projects for implementing new quality systems improvements
- Assist in in employee training program
- Maintain and track documentation for GxP projects
- Ensure compliant, accurate, and efficient control of controlled documents, such as master production records, labels, logbooks, laboratory notebooks, protocols, etc.
- Support on-site document storage solutions to ensure organization and timely retrieval mechanisms that support routine operations.
- Develop, write and revise procedures for operation of quality functions.
- Perform routine audits of Quality Systems logs and records for reconciliation purposes.
- Scan completed documents to maintain electronic copies of records.
- Support the development of Quality Systems training materials. Periodically train other staff members on records control procedures.
- Identify and implement continuous improvement opportunities within the quality management system.
- Other tasks / projects as assigned by Management.
Qualifications
- 2+ years of Quality Systems experience within the biotech or pharma industry - REQUIRED
- Need experience using Veeva Quality Vault (QualityDocs, Training, QMS).
- Must have experience as an admin in the system or experience with configurations of the system.
- Good understanding of current Good Manufacturing Practices (GMP) as related to document requirements.
- Strong MS Office skills (Word, PowerPoint, Excel, and SharePoint)
- Proven ability to work effectively cross functionality.
- Good verbal and written communication skills.
- Good problem-solving, troubleshooting and time management skills
- Proficiency with Microsoft and Adobe software applications.
- Ability to work independently with no supervision.
- Independence and comfort working in the fluid structure of start-up biotech.
- Quality Assurance experience supporting both development and commercial products is a plus.
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