Quality Assurance Documentation Specialist
Sabin Vaccine Institute
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $72,000 - $85,000 per year
About the role
- Manage and maintain controlled quality documentation, including SOPs, policies, forms, and work instructions, in compliance with applicable regulatory and industry standards.
- Participate in the implementation, administration and oversight of the document control process in Master Control, ensuring documents are reviewed, approved, released, and archived according to company procedures.
- Support the vendor qualification program, internal and external audits by ensuring documentation is accurate, accessible, and audit ready.
- Collaborate in cross-functional teams to support organizational needs.
- Ensure compliance with FDA, EMA, ICH, and other applicable regulatory requirements.
Requirements
- Bachelor’s degree in Life Sciences, Quality Assurance, Regulatory Affairs, Computer Science, or a related field preferred.
- Minimum of 4 years of experience in quality assurance, document control, or compliance within a highly regulated industry.
- Hands-on experience Master Control or similar electronic document management systems (EDMS).
- Strong knowledge of document control best practices and regulatory requirements (FDA 21 CFR Part 11, GxP, ISO standards).
- Excellent organizational, written, and verbal communication skills.
- Ability to manage multiple priorities while maintaining attention to detail.
Benefits
- Medical
- Dental
- Vision
- Flexible Spending Accounts
- Employer paid Life and Disability insurance
- 11 paid holidays
- 401(k) employer match
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
document controlquality assurancecomplianceregulatory requirementselectronic document management systemsMaster ControlSOPsGxPISO standardsFDA 21 CFR Part 11
Soft Skills
organizational skillswritten communicationverbal communicationattention to detailability to manage multiple priorities