LifeSprout Quality Control Analyst in Baltimore, Maryland
Position: Quality Control Analyst
Company Background: Founded in September 2015 as a spinout from Johns Hopkins University, LifeSprout is a medical device company developing the next-generation of soft tissue alternatives for aesthetic and reconstructive medicine. The company is led by a management team well-versed in the business, clinical, and scientific aspects of medical device company operation. LifeSprout is seeking a QC Analyst to support themanufacturing team by performing all critical QC inspections and other operations. LifeSprout?s first product, an injectable filler for soft tissue reconstruction, will be regulated as a Class III medical device under the PMA pathway; this will be followed by several products in earlier stages of development.
Position Overview: The Quality Control Analyst will have responsibility for performing incoming material, in-process component, and finished device inspections and lot release testing following approved protocols. Theanalyst will also assist in assay development, optimization, and validation efforts to ensure the accuracy oftest results.
Responsibilities:? Complete incoming material inspections for critical items.? Perform in-process component testing to verify compliance to approved specifications for furtherprocessing.? Execute finished device lot release testing as part of the dispositioning procedure.? Create and refine work instructions and inspection procedures.? Conduct trend analysis of test results to assist in setting of process limits.? Assist in validation efforts to ensure the reproducibility of various test methods.? Collaborate with other team members in the development and optimization of new test methods.? Assist in the qualification of new equipment introduced for new test methods.
Qualifications:? Undergraduate degree in chemistry, chemical engineering, materials science, biomedicalengineering, or a related discipline with 2-4 years experience in industry or academia.? Demonstrated ability to operate laboratory equipment such as analytical balances, microscopes,plate readers, and low-volume pipettes.? Demonstrated ability to execute on deliverables and manage milestones.
Preferred:? Previous work experience with inspection procedures/processes, specifically with asepticproducts.? Significant laboratory experience in executing quality control procedures.? Working knowledge of GMP manufacturing and testing processes, FDA and regulatory bodies,and quality systems.
Eligibility to work in the U.S. is required.