Quality Documentation Specialist

• Responsible for creating, reviewing, and maintaining quality documents to ensure compliance, accuracy, and accessibility.
• Manage the document control system, support regulatory compliance, and assist in quality assurance processes.
• Ensure that all quality documents meet required standards and regulatory guidelines, supporting continuous improvement and operational efficiency.

Key Duties

1. Manage an organization's information assets, including policies, procedures, technologies, and systems for collecting, managing, storing, and disseminating information.
2. Work closely with the Quality Documentation Specialist to maintain document integrity and ensure compliance with established procedures.
3. Develop and maintain quality documentation procedures, ensuring alignment with Quality Management Systems (QMS), GMP, and other regulatory standards.
4. Oversee and maintain electronic document management systems (EDMS) for proper storage, retrieval, and management of documents.
5. Collaborate with other departments to ensure quality documents are accurate, complete, and accessible.
6. Keep document management systems up-to-date, ensuring all documents are appropriately classified and indexed.
7. Maintain accurate records, manage revisions, and ensure all documentation is updated and distributed to relevant stakeholders.
8. Support the development and implementation of quality systems and processes to promote proper documentation practices.
9. Train staff on document control procedures, including creation, revision, approval, and distribution in compliance with company policies.
10. Oversee the lifecycle of documents from creation to archiving, ensuring timely review and compliance with retention requirements.

Qualifications

• Bachelor’s degree in a relevant field such as Life Sciences, Quality Management, Business Administration, or a related discipline.
• Certification in Quality Management Systems (e.g., Certified Quality Auditor (CQA) or ISO 9001 Lead Auditor) or Document Control.
• 3–7 years of quality or relevant process experience.
• Proven ability to lead and manage an onshore and offshore team.

The pay range that the employer in good faith reasonably expects to pay for this position is $30.97/hour - $48.40/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.

Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.

Salary : $31 - $48