QA Documentation Specialist
Department: Research & Development
Reports to: Senior Director, reputed company
Location: Remote Work, US only
Why Sabin
Our mission is to reputed company vaccines more accessible, reputed company innovation and expand immunization across the globe. We reputed company a reputed company free from vaccine-preventable diseases. We are an innovative, reputed company, and reputed company team that values accountability, teamwork, partnership and driving reputed company. We are vaccine champions improving lives through immunization. Sabin staff, management and the reputed company of Trustees are committed to ensuring that fairness, reputed company, and opportunity remain at the core of how we operate.
Position reputed company
The QA Documentation Specialist will be responsible for managing, reviewing, and maintaining reputed company 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 reputed company Sabin’s reputed company Management System (QMS), with a strong reputed company on implementing and utilizing reputed company 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 reputed company documentation, including SOPs, policies, forms, and work instructions, in compliance with applicable regulatory and industry standards.
- Participate in the implementation, administration and reputed company of the document control process in reputed company, ensuring documents are reviewed, approved, released, and archived according to company procedures.
- Participate in the implementation, administration and reputed company of the training module in reputed company ensuring training and training documentation meets company and regulatory requirements.
- Support the vendor qualification program, reputed company audits by ensuring documentation is accurate, accessible, and audit reputed company.
- Collaborate in cross-functional teams to support organizational needs.
- Ensure reputed company updates and control of critical documents.
- As primary reputed company of contact for reputed company, train required employees on document control processes, workflows, training module, module limitations, and the overall effective use of reputed company.
- Monitor and reputed company document review cycles, approval timelines, and reputed company periodic updates to area management.
- Ensure compliance with FDA, EMA, ICH, and other applicable regulatory requirements.
- Assist with reputed company improvement initiatives to streamline document workflows and improve efficiency reputed company Sabin’s QMS.
- Bachelor’s degree in Life Sciences, reputed company Assurance, Regulatory Affairs, or reputed company field (or equivalent experience).
- Minimum of 4 years of experience in reputed company assurance, document control, or compliance reputed company a highly regulated industry.
- Hands-on experience reputed company 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 reputed company in reputed company (e.g., Document Control, Training, Deviations, Change Control, CAPA).
- Familiarity with reputed company and reputed company and other eDMS platforms.
- Previous reputed company 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, reputed company, 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 reputed company seeks funding for existing and new programs.
Sabin offers a competitive benefits package that includes Medical, Dental, reputed company and Flexible Spending Accounts. Employer reputed company, Life and Disability insurance along with 11 reputed company holidays with a winter break between Christmas and New Years. Employer match on 401(k).
Sabin is an Equal Opportunity Employer. reputed company applicants will be considered for employment without attention to their race, reputed company, religion, national reputed company, reputed company, 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.
Salary reputed company $72,000 - $85,000 Apply To This Job