Laboratory Analyst I - Analytical Services Laboratory

MTF Biologics processes tissue grafts from human donors that are used in a growing array of clinical applications – positively affecting lives across the globe. As a global nonprofit organization that saves and heals lives by honoring donated gifts and serving patients, we collaborate with the medical, scientific, as well as organ and tissue donation communities.

Our goal is simple–do what's right for patients, surgeons, tissue donors, and their families through our guiding principles.

Responsible for ensuring that test method execution is performed in accordance to validated MTF procedures and regulatory standards set forth by AATB, FDA, TGA, and USP. All operational procedures are performed to ensure customer service between contract laboratories and departments within MTF. The Laboratory Analyst I will provide support to the team leader(s), laboratory supervisor(s), and manager(s) in the qualification, implementation, and continuation of test methods.

Monday-Friday , 8am-4pm

1. Responsible for performing test methods following laboratory systems of operation, current Good Laboratory Practices (cGLPs), current Good Manufacturing Practices (cGMPs) as well as current and approved laboratory operating procedures (OPs) and work instructions (WIs).
2. Performs laboratory assays, microbiological, physical and analytical testing as designated.
3. Reconciles all samples and maintains chain-of-custody documentation according to MTF documentation procedures.
4. Performs data review for sample throughput daily.
5. Annually reviews all OPs and WIs in Master Control for necessary testing and analyses.
6. Performs monthly calibrations on micro liter pipettes and/or thermometers.
7. Routinely operates and troubleshoots equipment, instruments and associated software.
8. Ensures test methods are performed within sample hold times.
9. Responsible for monitoring temperatures of laboratory incubators, freezers, refrigerators, water baths, ovens, etc.
10. Maintains calibration records for the lab and instrumentation as required.
11. Maintains proficiency and certification for all test methods that training has been completed.
12. Performs data entry functions using the LIMS (Laboratory Information Management System), QDDS, and the MTF email system as assigned.
13. Interfaces with QA, QE, laboratory management or team leaders for review and interpretation of test results.
14. Responsible for the cleaning and removal of biohazard waste and inventory within the laboratory.
15. Actively cooperates in training and retraining due to operation changes and/or document updates as required.

Performs additional duties as assigned and trained