Quality Control Associate, Materials jobs in United States
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Ossium Health · 1 month ago

Quality Control Associate, Materials

Ossium Health is dedicated to improving human health through bioengineering and cell therapy products. The Quality Control Associate, Materials is responsible for assessing quality systems to ensure compliance with standards and regulations, as well as inspecting raw materials and finished products.

BiotechnologyHealth CareLife Science
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Growth Opportunities
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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

Qualification

Life Sciences degreeFDA regulations experienceAseptic laboratory testingMicrosoft OfficeInterpersonal skillsCommunication skillsTime management

Required

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

2+ years of work experience in either: An FDA regulated recovery, processing or testing facility or Aseptic laboratory testing, microbial monitoring or cleanroom operations
Strong computer skills including Microsoft Office and database applications

Benefits

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

Company

Ossium Health

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Ossium Health builds a bone marrow bank to treat blood cancers.

Funding

Current Stage
Growth Stage
Total Funding
$128.87M
Key Investors
California Institute for Regenerative Medicine
2023-07-25Series C· $52M
2023-04-28Grant· $3.46M
2021-03-18Series B· $63M

Leadership Team

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Susannah Cantrell
Chief Commercial Officer
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Company data provided by crunchbase