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Quality Assurance Specialist at Ethos Biosciences

Posted in Manufacturing 30+ days ago.

Type: Full-Time
Location: Newtown Square, Pennsylvania





Job Description:

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:


  • Perform in-process and final product inspections as required and tag product as acceptable or non-conforming

  • Review batch records and forms for good documentation practices

  • Create customer certificate of Analysis (COAs) for review by QA team and forward to customers

  • Assist with root cause analysis of non-conforming product and product complaints

  • Assist with filing of quality documentation e.g., nonconformances, CAPAs, batch records, complaints, etc.

  • Perform incoming inspection on key packaging and components

  • Perform internal audits of high-risk processes

  • Participate in the preparation and review of QA files for customer and ISO onsite audits and regulatory inspections; assure that QA audit files are retained.

  • Participate in customer, ISO, and regulatory audits/inspections.

  • Manage customer complaints and non-conformance databases

  • Perform all other related duties as assigned

Education / Experience:


  • Associate’s degree in life science or related discipline and a minimum 3 years’ experience required in a Quality Assurance role or a cGMP environment


  • OR a minimum of 8 years’ experience in a Quality Assurance role or a cGMP environment


  • OR a Bachelor’s degree preferable in a life science or related discipline and 1 year of experience in a Quality Assurance role or cGMP environment.

  • Knowledge of Microsoft Office applications (e.g., Word, Access, Excel, PowerPoint).

  • Auditor training to ISO 13485 or ISO 9001 preferred

  • Able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements.

  • Proficient judgment, decision-making, training/mentoring skills and verbal/written communication skills.

  • Strong leadership, organizational skills, and detail oriented.

  • Able to prioritize workload and manage multiple tasks

What We Offer

Culture


  • Great people, Peer to Peer Recognition, Broader, hands-on work experience

  • Clean and Modern Equipment & Labs, Fun company events

  • Competitive Wages & Generous Year-end Bonus

  • Comprehensive Benefits

  • 4 Medical PPO Medical Plans with Telemedicine, Rx, & Vision, 2 Dental Plans

  • Healthcare, Dependent care, & Commuter Flexible Spending Accounts, 401(k) with company match, Financial Health & Wellness w/1:1 Coaching,

  • Basic & Supplemental Life Insurance, Accident, Hospital Indemnity, & Critical Illness, Paid Time Off, Short & Long-term Disability, 9 Paid Holidays

  • Must have legal authorization to work in the US and will not require sponsorship.

  • Polysciences is an equal opportunity employer. Drug-free workplace. Tobacco-free work site.

  • Polysciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.  All employment is decided on the basis of qualifications, merit and business need.

  • Equal access to programs, services, and employment is available to all persons.  Those applicants requiring reasonable accommodation to the application process and/or interview process should notify a representative of the Human Resources Department.




Salary: $62,500.00


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