QA Specialist
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
Ethos Biosciences, Inc, is a subsidiary of Ott Scientific - a 350 person global, diversified, privately held company. 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 have a brand new facilities a 126,000 ft2 manufacturing facility in Logan Township, NJ. 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. 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 entry level Quality Assurance Specialist / Technician willing to learn, understand, and apply 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), control of nonconforming products, change control, corrective and preventative actions, root cause analysis, calibration, and internal audits.
RESPONSIBILITIES:
- Review batch records and forms for good documentation practices
- Post batch records in ERP system and green tag approved final product
- Review customer certificate of Analysis (COAs)
- Assist with root cause analysis of non-conforming product and product complaints
- Scan and file all quality documentation e.g., nonconformances, CAPAs, batch records, complaints, etc.
- Perform incoming inspection on key packaging and components
- Assist with internal or spot audits
- Participate in the preparation and review of QA files for customer and ISO onsite audits
- Update various databases e.g., customer complaints, non-conformance, CAPAs etc.
- Review production line and equipment logbooks for completeness and good documentation
- Perform all other related duties as assigned
- Education / Experience:
- Associate’s degree in life sciences or a related discipline and a minimum of one year work experience
- OR a high school diploma and a minimum of 4 years’ work experience preferably in a quality assurance role or in a manufacturing environment
- Knowledge of Microsoft Office applications (e.g., Word, Access, Excel, PowerPoint, Outlook, Teams).
- Able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements.
- Proficient judgment, decision-making, 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.
Ethos Biosciences is an equal opportunity employer. Drug-free workplace. Tobacco-free work site.
Ethos Biosciences 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.
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