Posted in Manufacturing 30+ days ago.
Type: Full-Time
Location: Newtown Square, Pennsylvania
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 offer products and services through American Bionostica for lateral flow products, Astral Diagnostics for histology and hematology stains and reagents, Astral Rx for pharmaceutical formulations, and Exocell for research and clinical nephrology assays. Our operations and areas of expertise allows us to seamlessly deliver contract development and cGMP manufacturing services.
Ethos Biosciences, Inc, is a subsidiary of Ott Scientific - a 350 person global, diversified, privately held company headquartered in the Greater Philadelphia Area. Ethos Biosciences designs, develops, and manufactures high quality products that are accurate, repeatable, and easy to use. We exist to drive healthcare innovation by providing diagnostic tools for scientists and practitioners. Our vision is to be the leading provider of assays and reagents for specialty indications and applications. We recently combined four Ott Scientific subsidiaries into one consolidated company to efficiently utilize our scientific development and manufacturing capabilities across one platform.
We have two brand new facilities a 12,000ft2 research facility in Newtown Square, PA and a 126,000 ft2 manufacturing facility in Logan Township, NJ. Ethos Biosciences consists of four product lines: Astral Diagnostics (dyes, stains and reagents), Exocell (nephrology ELISAs), American Bionostica (lateral flow assays) and AstralRx (pharmaceutical manufacturing). The business engages in contract development and manufacturing (CDMO) for leading diagnostics and lab product distributors and directly markets products under our own brands to clinical, biotech and university labs.
SUMMARY:
We are looking for a Quality Assurance Specialist / Technician with knowledge and understanding of current good manufacturing practices (cGMP) and ISO 13485 quality management systems for medical devices. This includes but is not limited to good documentation practices (GDP), design controls, control of nonconforming products, change control, corrective ad preventative actions, root cause analysis, calibration, and internal audits.
RESPONSIBILITIES:
Education / Experience:
What We Offer
Culture
Salary: $62,500.00
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