What are the responsibilities and job description for the QA Specialist, Document Control position at Ossium Health?
Ossium's mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good.
About the Job
We're looking for a highly organized, detail-oriented, and self-motivated Document Control Specialist to manage the approval of controlled documents within our Quality Management System (QMS). In this critical role, you'll be responsible for overseeing the entire document lifecycle, ensuring documentation is accurate, secure, and audit-ready. Your day-to-day work will be instrumental in maintaining our compliance with critical regulatory standards, positioning you as a key player in our ongoing success.
You will work across departments, offering guidance on document control best practices, ensuring all documents meet regulatory requirements, and driving projects to successful completion. You will review the content of documents against the regulations and standards, suggest edits to the content, ensure consistent formatting, and obtain all required approvals. We'll also rely on you to suggest opportunities for improvement to existing workflows and lead document control process enhancements. As a vital part of the team, you will ensure smooth document control operations across both sites and play a crucial role in the achievement of the organization's new initiatives. You will report to the Manager, Quality Assurance and be part of a dedicated team committed to excellence and the safety of our patients.
Required Qualifications
- Associate's Degree and 2 years of relevant experience in a Quality Management System document control role or 4 years of relevant experience in a Quality Management System document control role
- Experience in CGTP, CGMP, AATB, and/or CLIA-regulated environments
- Proficiency in document management software, Microsoft Office, and G Suite
- Experience with operating within electronic Quality Management System (eQMS)
- Excellent written and oral communication skills
- Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
- This position is based in our Indianapolis office and offers the flexibility of a hybrid work schedule. Employees will report to Ossium's facility Monday through Thursday and have the option to work remotely on Fridays.
Preferred Qualifications
- Experience working in a startup or high-growth biotech environment
- Experience with MasterControl eQMS system
- Working knowledge of FDA, ISO, or other regulatory requirements relevant to tissue, cell, or biologics industries
- Bachelor's Degree in Life Sciences or Chemistry
- Experience supporting or leading document control efforts during regulatory audits or inspections
- Ability to analyze and improve document workflows and implement scalable document control processes
- Prior experience working with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs
Key Responsibilities
- Manage and maintain controlled documents, including SOPs, ensuring proper classification, version control, and secure storage
- Perform QA reviews and maintain readiness for internal and external audits
- Create and uphold document control systems and procedures that align with CGxP, AATB, and CLIA standards
- Digitize physical documents and manage true copy conversions
- Collaborate with stakeholders across Production, Manufacturing, and Quality Control teams
- Support ongoing improvements to the QMS and contribute to the development of best practices
- Stay current on industry standards and ensure documentation remains compliant
In your first six months some projects you'll work on include:
- Completing training & becoming the point of contact for controlled document status
- New document and revision request & tracking optimization
- QMS Audit Readiness Preparations
We offer a full slate of employee benefits including:
- Competitive salaries
- Stock options
- 401(k) matching
- Medical, dental and vision coverage
- Four weeks of PTO accrued (vacation & sick time) annually 11 company holidays
- Employer paid life insurance and long term disability
- Gym membership/recreational sports reimbursements
