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Quality Control Associate

2 weeks ago

Indianapolis, Indiana, United States Ossium Health Full time
About the Job

We're looking for a Quality Control Associate to provide technical support and execution of tasks 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 a basic understanding of the theory, concepts and regulations behind cGMP regulations and CLIA regulations. You'll help to ensure that we maintain the highest levels of quality and safety standards on a day to day basis. This is a great opportunity for detail-oriented individuals looking to further a career in biotechnology and quality systems.

Required Qualifications
  • BS or BA in biological sciences
  • 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 full time in our Indianapolis facility
Preferred Qualifications
  • Experience working in a CLIA laboratory, cell therapy, tissue banking, blood banking, or other relevant industry experience
  • Experience with flow cytometry, hematopoietic colony forming unit assay, ELISA, and colony forming unit fibroblast assay
  • 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
Key Responsibilities
  • Perform tests as operator or verifier in the testing of bone marrow derived products
  • Maintain data and documentation related to testing of bone marrow derived products obtained internally or externally
  • Update product and sample inventory using an electronic inventory system
  • Assist in shipping of testing samples and product from bank
  • 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
Physical Requirements
  • Must be able to work aseptically in controlled environments requiring special gowning (ie. over the head, face, hands, feet and body)
  • Must be able to work in a moderately noisy environment
  • Must be able to work around biohazardous materials and chemicals
  • Must be able to lift, push, pull and/or carry up to 25 lbs
  • Must be able to use hands and fingers to handle and feel objects, tools, and controls
  • Must be able to sit or stand for long periods of time. Regularly required to sit, stand, walk, climb, stoop, kneel, crouch; use hands to handle or feel; and reach with arms.
Schedule
  • Full-time (40 hours per week)
  • This is an hourly, non-exempt role that is eligible for overtime
  • Our QC lab is staffed for testing Monday through Friday, including holidays. The schedule for this position is 4 x 10 hour shifts either Monday-Thursday or Tuesday-Friday

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 or 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