Quality Control Specialist, ELISA

About the Job

Were looking for a Quality Control Specialist to provide technical support and execution of ELISA testing within Ossium Healths 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. Youll 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
• 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 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 youll 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