Quality Control Scientist - Ethos Biosciences, Inc.

Who We Are

Ott Scientific

The Ott Scientific family of companies comprises Polysciences, Bangs Laboratories, and Ethos Biosciences. Together, we bring the whole of our experience with best-in-class facilities and scientific, technical, analytical, and manufacturing capabilities to serve customers around the globe. We deliver highly specialized products and services that support scientific discovery and innovations.

Ethos Biosciences

At Ethos Biosciences, we are a contract development and manufacturing organization (CDMO) that offers private label manufacturing to many of the biggest life science and diagnostic companies around the world. Our core competencies are immunoassays (ELISA/Lateral Flow) as well as specialty and high volume diagnostic stains, buffers, and reagents. Our laboratories, manufacturing suites, and warehouse areas are purpose built to accommodate these specialty manufacturing and development operations. We occupy a newly built, state of the art, 126,000ft² stand-alone building in Logan Township, NJ. Proud to be part of Greater Philadelphia, we are 25 miles from Cherry Hill, NJ, 25 miles from Villanova, PA, and 16 miles from Wilmington, DE. Our processes are governed by an ISO 13485/FDA 820 Medical Device certified quality management system (QMS). We exist to drive healthcare innovation by providing diagnostic tools for scientists and practitioners. Everyday we design, develop, and manufacturing diagnostic products that are accurate, repeatable, and easy to use. Our vision is to provide gold standard assays for novel biomarkers and critical reagents to institutions pioneering biomedical research and practice.

Responsibilities

• Perform Quality Control testing of raw materials, in-process and finished product sample per internal and customer specifications and associated test methods
• Work under cGMP, GLP, ISO, and other quality standards
• Support on-time testing performance against the Production Schedule
• Ensure equipment and instruments are maintained for optimal performance, including calibration, preventative maintenance, and qualification for use.
• Assist in maintenance and troubleshooting of QC lab equipment to minimize downtime
• Assist with OOS, Deviations, and NC/CAPA investigations. Lead or participate in troubleshooting customer complaint investigations.
• Maintain a safe, clean, and organized environment for all QC areas
• Employ sound and compliant laboratory techniques and logic per industry standards (e.g. FDA, USP/NF, ISO, ANSI) and internal and customer requirements.
• Keep management informed of any quality related issues that arise in the laboratory or with finished products.
• Assist in QC stability testing, prepare and maintain stability records and summaries
• Report monthly on supplies for QC orders involving devices and reagents
• Participate in special projects via input, feedback, and execution of assigned tasks
• Conduct data reviews to ensure completeness and accuracy of records
• Monitor and/or perform inspections and control of components, products, and materials in accordance with specifications and work instructions.
• Assist in supervising the laboratory and monitor/track daily lab functions.
• Assist in reporting KPIs and equipment SPCs.
• Assist in test method validations.

• Experience working as a medical laboratory scientist, preferred.
• A minimum of 5 years working in a laboratory environment.
• Intermediate knowledge of analytical equipment, analytical methods, and data analysis
• Bachelor’s degree in biology or related field
• Fluent in the English language with the ability to read and write
• Ability to work in coordination with other team members to accomplish goals
• Ability to work in a fast-paced distribution environment while meeting established performance quotas and standards
• Ability to work standing for long periods of time with frequent stooping or bending
• Detail oriented, quality focused and self-motivated
• Adaptable, willing, and expected to support all operational tasks within the facility as requested