QA Documentation Specialist

Department: Research & Development

Reports to: Senior Director, Quality

Location: Remote Work, US only

Why Sabin

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.

Position Summary

The QA Documentation Specialist will be responsible for managing, reviewing, and maintaining quality system documentation and supporting documentation in compliance with regulatory standards and organizational policies. This role will play a key part in ensuring document accuracy, control, and accessibility within Sabin's Quality Management System (QMS), with a strong focus on implementing and utilizing MasterControl for document lifecycle management.

The ideal candidate has a keen eye for detail, excellent organizational skills, and experience working in regulated environments (e.g., pharmaceutical, biotechnology, vaccines, or life sciences). Including previous experience in managing, implementation and administration of Master Control QMS modules.

Key Responsibilities

• 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 MasterControl, ensuring documents are reviewed, approved, released, and archived  according to company procedures.
• Participate in the implementation, administration and  oversight of the training module in MasterControl ensuring training and training documentation meets company and regulatory requirements.
• 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 timely updates and control of critical  documents.
• As primary point of contact for MasterControl, train required employees on document control processes, workflows, training module, module limitations, and the overall effective use of MasterControl.
• Monitor and track document review cycles, approval timelines, and provide periodic updates to area management.
• Ensure compliance with FDA, EMA, ICH, and other applicable regulatory requirements.
• Assist with continuous improvement initiatives to streamline document workflows and improve efficiency within Sabin's QMS. 

• Bachelor's degree in Life Sciences, Quality  Assurance, Regulatory Affairs, or related field (or equivalent experience).
• Minimum of 4 years of experience in quality assurance,  document control, or compliance within a highly regulated industry.
• Hands-on experience MasterControl 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.

 Preferences

• Exposure or experience in the pharmaceutical,  vaccine, or biotechnology industries, cGMP and required regulatory  compliance.
• Experience implementing, training and administration  of QMS modules within in MasterControl (e.g., Document Control, Training, Deviations,  Change Control, CAPA).
• Familiarity with Box and ZenQMS and other eDMS  platforms.
• Previous oversight of eQMS controlled document  systems supporting audits or regulatory inspections.

Core Competencies

• Attention to detail and accuracy.
• Strong problem-solving and critical-thinking skills.
• Ability to work independently and collaboratively in  a cross-functional team.
• Adaptability and willingness to support evolving  Sabin's QMS needs.

Sabin's philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the starting annual salary for this position ranges from $72,000 - $85,000. The exact compensation may vary based on skills, experience, training, certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs.

Sabin offers a competitive benefits package that includes Medical, Dental, Vision and Flexible Spending Accounts. Employer paid, Life and Disability insurance along with 11 paid holidays with a winter break between Christmas and New Years. Employer match on 401(k).

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.