Job Description
We are seeking a detail-oriented Document Control Specialist to support the Quality Operations team in a highly regulated environment. You will be responsible for the full lifecycle, control, and governance of critical quality documentation. The ideal candidate will serve as a subject matter expert, ensuring that all records remain compliant with Good Practice (GxP) standards and are consistently inspection-ready.
Core Objectives
- Lifecycle Management: Own the end-to-end process for quality documentation-from creation and revision to issuance, archiving, and retirement.
- Regulatory Compliance: Ensure all documentation adheres to established quality standards and regulatory expectations.
- System Stewardship: Serve as the primary user for electronic document management systems, facilitating workflows and maintaining accurate, traceable repositories.
- Inspection Readiness: Lead periodic reviews and gap assessments to proactively identify documentation risks and ensure the organization is always prepared for external audits.
- Strategic Collaboration: Partner with cross-functional teams to provide guidance on document control best practices and assist in the documentation strategy for new processes.
Qualifications - Experience: Minimum of 4 years of experience in document control within a highly regulated pharmaceutical, biotechnology, or medical device environment (GxP).
- Technical Proficiency: Required hands-on experience with Veeva QualityDocs.
- Domain Knowledge: Detailed understanding of quality policies, document control principles, and regulatory requirements.
- Compliance: Demonstrated success in supporting regulatory inspections, audits, and remediation projects.
- Communication: Strong written and verbal skills, with the ability to influence stakeholders and provide clear guidance across various departments.
- Education: Bachelor's degree or equivalent professional experience.
- Analytical Rigor: Exceptional attention to detail, organizational skills, and the ability to manage multiple high-priority deliverables simultaneously.
Equal Opportunity Employer / Disabled / Protected Veterans
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For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.
AllSTEM Connections participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Additional Skills (none specified)
AllSTEM Representative Contact Info Account Executive: Giampaolo
Branch Phone: (909) 244-1777
Location: Ontario, CA
Job Tags
Temporary work