Ossiums 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
Were looking for a highly organized detailoriented and selfmotivated Document Control Specialist to manage the approval of controlled documents within our Quality Management System (QMS). In this critical role youll be responsible for overseeing the entire document lifecycle ensuring documentation is accurate secure and auditready. Your daytoday 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. Well 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 organizations 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
- Associates 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 CLIAregulated 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 Ossiums facility Monday through Thursday and have the option to work remotely on Fridays.
Preferred Qualifications
- Experience working in a startup or highgrowth biotech environment
- Experience with MasterControl eQMS system
- Working knowledge of FDA ISO or other regulatory requirements relevant to tissue cell or biologics industries
- Bachelors 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 crossfunctional 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 youll 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
Ossium Health provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race color religion sex national origin age disability protected veteran status sexual orientation gender identity or gender expression. Pursuant to the San Francisco Fair Chance Ordinance we will consider for employment qualified applicants with arrest and conviction records.
Principals / direct applicants only please. Recruiters please do not contact this job poster.
Equal Opportunity Employer/Veterans/Disabled
Required Experience:
Unclear Seniority