The Quality Control (QC) Specialist will be responsible for daily QC operations for TMRW Life Sciences, Inc. The QC Specialist will work primarily from the warehouse located in Indianapolis, IN. The position will also have intermittent responsibilities at client facilities and at the New York headquarters. The QC Specialist reports directly to the Quality & Regulatory Affairs Manager.
Key Duties & Responsibilities:
Batch Record review; final product release
Raw material and final product inspection
Internal Audit execution
Prepare monthly and quarterly metrics
Develop and implement Quality Control procedures for the warehouse environment
Assist in the development of Quality Specifications
Assist in the development of Quality Control procedures for contract manufacturers
Perform Risk Assessments and Hazard Analysis
Lead Material Review Board (MRB) meetings
Review and disposition Validation Reports
Intake and escalation of Nonconformance Reports and Customer Complaints
Approximately 30% domestic travel
Other duties as assigned
Minimum of three years’ experience in a regulated industry, preferably medical device
Minimum of a bachelor’s degree in a Life Sciences field
ISO 9001 and/or ISO 13485 experience preferred
FDA and/or EU MDD/MDR experience preferred
Skilled in technical writing
Skilled in Microsoft Word, Microsoft Excel, and Microsoft PowerPoint
Energetic, highly motivated, and results-driven
Strong organizational skills, attention to detail, ability to prioritize and multi-task
Additional Salary Information: Based on experience level.
About TMRW Life Sciences, Inc.
Developed in partnership with leading fertility doctors and embryologists, TMRW’s technology significantly reduces risk to the precious and fragile cells and tissues used in IVF. Our robotic process automation radically improves the identification, freezing and storage of reproductive cells and embryos—putting an end to the error-prone manual and analog methods that have gone unchanged since IVF was first used in animal husbandry more than fifty years ago. Our automation eliminates 20% of the time required to perform manual tasks in the embryology lab, allowing embryologists to focus on the most skilled and technical aspects of their work.
TMRW provides a 100% digital chain of custody. This includes continuous local and remote electronic monitoring with integrated processes producing 10,000 daily digital signals which are used to constantly monitor, maintain and safeguard the integrity and security of the reproductive cells in our care.
As requested by our physician partners, the TMRW platform is designed for both in-clinic and remote storage.
The TMRW team includes many of the world’s most celebrated pioneers in clinical medicine, reproductive biology and embryology, vitri...fication, and cryogenic biobanking who have synthesized their collective knowledge, vision and experience in the development of the TMRW system.