Quality Control Specialist, ELISA

Ossium HealthIndianapolis, IN
8dOnsite

About The Position

We’re looking for a Quality Control Specialist to provide technical support and execution of ELISA testing within Ossium Health’s Quality Control Laboratory, relating to testing of human bone marrow-derived materials for pre-clinical and clinical use. Successful candidates have an understanding of the theory and concepts of ELISA testing. You’ll help to perform in-process testing of clinical samples and validate new methods. This is a great opportunity for detail-oriented individuals looking to further a career in biotechnology and quality systems. This position reports to our Manager, Quality Control.

Requirements

  • BS or BA in biological sciences
  • 2+ years of practical experience performing ELISA testing within a life sciences, biotech, or clinical laboratory environment
  • High level of attention to detail in both operations and documentation
  • Reliable and able to produce consistent, high quality work
  • Great communication skills and organization, able to work as part of a team
  • Great work ethic and positive attitude
  • Strong computer skills, including Microsoft Office
  • Strong attention to detail and observational skills
  • This position is based onsite, full time in our Indianapolis facility

Nice To Haves

  • Experience working in a CLIA laboratory, cell therapy, tissue banking, blood banking, or other relevant industry experience
  • Experience in testing hematopoietic stem cells
  • Exceptional laboratory technique
  • Understanding of 21 CFR 210, 21 CFR 211, 21 CFR 1271, 42 CFR 493, AATB Standards, and other GMP requirements
  • Strong knowledge of data analysis and statistical methods
  • Hands-on experience in MasterControl, including the quality modules and production records

Responsibilities

  • Perform ELISA tests as operator or verifier in the testing of bone marrow derived products
  • Perform and write method validations and validation reports for new testing procedures
  • Maintain data and documentation related to testing of bone marrow derived products
  • Update product and sample inventory using an electronic inventory system
  • Perform routine and advanced duties required to clean, maintain and operate testing equipment and storage equipment
  • Assist in drafting and revising of departmental procedures
  • Work with coworkers and supervisor to effectively troubleshoot equipment and testing issues

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
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