Part-Time Document Control Associate I
TLDR
Collaborate with the Quality & Regulatory team to maintain document control systems and ensure compliance with Quality Management System (QMS) requirements.
Your next role as a Miracle Maker
Maravai LifeSciences is seeking a #MiracleMaker to join our Quality & Regulatory team as a Part-Time Document Control Associate I. As a Part-Time Document Control Associate I, you will be responsible for maintaining the document and record control systems and ensuring they meet Quality Management System (QMS) requirements. This position is responsible for coordinating the issuance, revision, review and approval of SOPs and other documents.
How you will make an impact:
- Issue document change order numbers, route and track new and revised documents for approval, file controlled documents and other documentation provided to QA, and ensure that all documentation follows the change control procedures
- Review documents for completeness, adherence to company guidelines on formatting, and authorization for approvals
- Monitor status of in-process document changes to ensure timely completion
- Organize filing systems for electronic and paper based GMP/research documents
- Support the establishment and improvement of quality systems
- Facilitate continuous improvements efforts of quality systems
- Assist in quality audits, including document preparation and record retrieval.
- Update and maintain quality metrics as needed
- Support after hours and weekends as needed
- Perform other functions and duties as required
The skills and experience that you will bring:
- BS Degree in scientific area preferred.
- Minimum of 1-2 years hands-on experience with document control management, preferably in a life science industry
- Experience with ISO 9001, ISO 13485, 21CFR820, 21CFR 211, or other regulated industry a plus.
- Experience with MasterControl or other document management system a plus but not required.
- Demonstrated ability to work independently and as part of a team
- Good writing skills, high degree of organization and excellent attention to detail.
- Good computer skills with working knowledge of MS office suite and Adobe Acrobat.
- Must be able to support after hours and weekend as needed.
- Self motivated and able to organize and prioritize multiple tasks.
#LI-Onsite
Maravai LifeSciences empowers biotech, biopharma, and life sciences companies by providing critical products and services in nucleic acid production and biologics safety testing. We enable the development of novel vaccines, therapeutics, and diagnostics, positioning ourselves as trusted partners for industry leaders in the pursuit of innovative healthcare solutions.