Quality Control Associate

Ossium Health•Indianapolis, IN

43d•Onsite

About The Position

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.

Requirements

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
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.

Nice To Haves

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

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