Quality Control Specialist, ELISA

About the Job

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.

Required Qualifications

• 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

Preferred Qualifications

• 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

Key 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

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

• Completing training on established ELISA tests on bone marrow derived products
• Performing testing as part of new method validations
• Assisting in the writing of method validation reports

Physical Requirements

• Must be able to work aseptically in controlled environments requiring special gowning (i.e. 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
• The schedule for this position is Monday - Friday, 9am to 5pm

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