Posted 2 weeks ago
NovaBay Pharmaceuticals/Emeryville, CA
Job Title: Quality Assurance 3
Location: Emeryville, California
Position Type: full time, non-exempt
Base Salary: $75,000 – $90,000
About the Company:
NovaBay Pharmaceuticals, Inc. is a biopharmaceutical company developing products for the eye care market. We are currently focused primarily on commercializing prescription Avenova® for managing hygiene of the eyelids and lashes in the United States. Avenova is the only eye care product formulated with a proprietary, stable and pure form of hypochlorous acid called Neutrox®. By replicating the anti-microbial chemicals used by white blood cells to fight infection, Neutrox has proven in laboratory testing to have broad antimicrobial properties. Avenova with Neutrox removes debris from the skin on eyelids and lashes without burning or stinging.
We have developed additional commercial products containing Neutrox, including our NeutroPhase® Skin and Wound Cleanser for wound care and CelleRx® for the dermatology market. We have partnerships for NeutroPhase in the U.S. as well as select overseas markets, most notably China.
In addition to our Neutrox family of products, we have also synthesized and developed a second category of novel compounds aimed at harnessing the power of white blood cell chemistry to address the global, topical anti-infective market. This second product category includes auriclosene, our lead clinical-stage Aganocide® compound, which is a patented, synthetic molecule with a broad spectrum of activity against bacteria, viruses and fungi.
The Quality Assurance Associate will become a significant contributor to the NovaBay team in compliance. In this important role you will be part of a dynamic QA team, leading compliance efforts to ensure continuing compliance to ISO 13485 and FDA regulations at NovaBay and NovaBay’s suppliers. You will be a critical member contributing to continuous development of the NovaBay GMP training program.
• Trusted Key Member Supporting Our QA Team: Focus on supporting internal and supplier compliance to ISO 13485 and FDA regulations by performing qualification audits, ensuring that non-conformances, deviations, CAPAs and audit items are addressed timely.
• Owner of Compliance Targets: Conduct internal and supplier audits timely, ensure that audit action items are closed timely while developing a positive and creditable working relationship with others. Identify and implement QMS areas of improvement.
• Significant Contributor into Continuing Development of GMP Training: Provide GMP training, qualification and follow up. Develop further the GMP training program while working to ensure QMS is suitable and effective at NovaBay.
• Support Quality Team: Provide QA support to colleagues as needed.
• 5+ years of experience in medical device industry and pharmaceuticals preferred.
• Demonstrated knowledge of ISO 13485 and FDA 21 CFR 820 and 210/211. Certified lead auditor to ISO 13485 preferred.
• 2+ years QMS and supplier auditing, SOP development and CAPA investigations experience
• Positive attitude and high integrity.
• Excellent written, verbal and interpersonal skills.
• Results-oriented, proven ability to meet targets.
• Team player
For consideration, please submit a cover letter with your resume and salary requirements by e-mail to:
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