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

The Quality Control Associate, Materials is responsible for assessing and reviewing the quality systems used to evaluate if products are being processed in compliance with internal/external standards, regulations, contractual agreements, policies, and procedures. The Quality Control Associate, Materials must be able to continually adapt to the evolving regulatory landscape.

This individual will report to the Quality Control Manager and work closely with members of the Quality Assurance and Supply Chain teams. As a member of the quality control team, this position will be responsible for the inspection of in process and finished cell products and release of starting materials. Additionally, the position will be responsible for the execution and monitoring of material inspections as well as assisting in the development or modification of internal systems.

Required Qualifications

Bachelor of Science degree in Life Sciences discipline
Capable of effectively assimilating information from visual inspection, written documents, and verbal inputs and identifying potential compliance risks
High level of professionalism and good judgment
Demonstrated strong interpersonal skills including excellent communication skills and attention to detail
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 full time in our Indianapolis office, Monday through Friday, and may have the occasional opportunity to work from home on Fridays based on business needs
Qualified candidates must be legally authorized to be employed in the United States; Ossium is unable to provide sponsorship for employment visa status (eg, H-1B or TN status) for this position, either now or in the future

Preferred Qualifications

2+ years of work experience in either:

An FDA regulated recovery, processing or testing facility
Aseptic laboratory testing, microbial monitoring or cleanroom operations

Strong computer skills including Microsoft Office and database applications

Key Responsibilities

Perform inspection and release of raw materials
Perform inspection of in process and finished cell products.
Provide quality support by resolving raw material and in-process material issues
Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends regarding materials
Perform and write deviations, nonconformances, and investigations as required
Design, review and approve/reject batch-related documentation, test methods, procedures and reports, and monitor all compliance to procedures escalating discrepancies
Provide on-the-floor oversight in GMP cleanroom and laboratory environments and support to ensure compliance to GMP regulations throughout those areas
Coordinate change controls and the documentation of the risk assessments, change documents, implementation of change, and objective evidence of the change in a compliant manner
Capture metric information for use in continuous improvement of areas of responsibility and report to management, as needed
Support regulatory filings through participation in data gathering

In your first six months some projects you’ll work on include:

Releasing raw materials for production of clinical products
Developing and revising materials testing procedures
Gathering data for continuous improvement and regulatory compliance

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, gender expression, or any other protected characteristic. Our Equal Employment Opportunity Policy Statement and the Know Your Rights: Workplace Discrimination is Illegal Poster reaffirm this commitment. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

If reasonable accommodation is needed, please contact our People Team at careers@ossiumhealth.com or 650-285-0603. Ossium Health complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities.

Principals / direct applicants only please. Recruiters, please do not contact this job poster.

Equal Opportunity Employer/Veterans/Disabled

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