Quality Assurance Specialist APPLY NOW

San Diego
Full time

About the Role:

Uqora’s Quality Assurance Specialist will play an important role in monitoring and optimizing Uqora’s quality management processes. This role will support the operations organization, while functioning as the primary quality contact for the Uqora and Equelle brands. The successful candidate will create and manage flexible and compliant processes and inspection programs that can effectively support a diverse supply-chain of supplement, OTC, and medical device products. You’ll build relationships with our vendors and suppliers and collaborate on risk mitigation to deliver quality improvements that ensure we continue to provide our customers with the highest quality products.

Who you are:

Multi-tasker: Juggling multiple projects simultaneously is a breeze for you. You know how to prioritize and you never let a ball drop.

Champion of continuous improvement: You value iterative improvement and believe that no matter how well systems and processes function, improvements can and should be pursued.

Problem solver: You have a knack for breaking down and solving complex problems while keeping a customer-first mindset. You’re able to identify stakeholders, estimate impact, spot opportunities, and leverage feedback loops while working through challenges.

Organized: Organization is at the core of everything you do. You thrive in creating clear, organized, repeatable processes.

A sampling of what you’ll be doing:

Working cross-functionally with science/R&D, operations, regulatory, and marketing teams in developing, editing, and reviewing product specifications, product labels.

Reviewing all product non-conformances and product health-related concerns.

Trending and remediation of product non-conformances including communication with co-manufacturers.

Own the relationship with external partners who monitor and report product health-related concerns. Trending, continual review, and maintenance of the adverse reporting system

Assist in the creation, maintenance, and approval of all Standard Operating Procedures relevant to the supply chain of all products.

Providing disposition of all finished products, owning visual QA procedures and/or approval steps in any automated and manual systems.

Assist in the final disposition remediation activities, if the product is to be disposed of assuring the required documentation is obtained, in rework, situations assure the proper documentation is submitted for approval prior to reworking.

Participate in all recall and mock recall activities.

Maintaining the supplier qualification program and all associated quality activities including laboratory activities.

Serve as the primary contact in all regulatory audit situations.

Assure all samples are obtained and submitted as needed for any external qualification programs and ongoing testing protocols. (Tested to be Trusted)

Continual maintenance of the overarching Quality Management System by assuring all pillars are maintained and updated as needed.

Providing monthly updates to the team as to the current state of quality within the business unit.

Maintain and manage QA communication with external consultants.

Pioneer our supply chain transparency program, giving customers greater visibility to our ingredient sourcing and quality.

Required/Preferred experience:

A four-year degree, a chemistry, biology or related science degree is preferred or equivalent “hands on” experience.

Two or more years in a similarly regulated industry dietary supplements, pharmaceuticals, medical devices and/or cosmetics.

A solid understanding of Good Manufacturing Practices (cGMP) applicable to parts CFR 111, 210, 211, 710, 720, and 820.

Experience working with contract manufacturers and laboratories.

Certification is not required, but a Quality Society (AQS) certification in auditing, GMP compliance or other quality related discipline is preferred.

Details:

-Based in San Diego, CA

-Full-time, salaried

-Generous PTO policy (unlimited)

-Health, vision and dental benefits

HOW TO APPLY

Using the form below, please submit your resume. We know you’re more than a resume and would love to hear from you as part of your application. In the body of your email please answer the following questions and limit your response to no more than 5 sentences per question:

-How would you go about building a QMS for a company? What areas would you tackle first? How would you prioritize?

-Outline what aspects of a supplier qualification program you think are most important to consider.

About us:

Uqora makes innovative UTI relief products and proactive care supplements.

UTIs are the second most common infection in the U.S., second only to the common cold. Despite the magnitude, there’s been little progress and innovation for years. Uqora is proud to be changing that.

Since launching in 2017, Uqora’s been able to help over 250,000 people stay healthy. Uqora is very focused on creating exceptional products and a vibrant, collaborative community of customers. Recently, Uqora was acquired by Pharmavite, the owner of Nature Made, which will enable Uqora to go deeper on research and expand its reach.

Uqora is growing quickly! In this position, you’ll have the opportunity to make a meaningful impact on expanding Uqora’s reach by educating and engaging our audience and customers.

You’ll also have the opportunity to make an impact on Uqora’s sister brand, Equelle, a quickly growing brand helping women tackle menopause symptoms in a new way.

Equelle’s novel, innovative approach to menopause symptom management has been validated in three clinical trials, and its active ingredient, S-equol, has been scientifically studied for over 20 years.

Aside from providing breakthrough relief with science-backed products, this emergent brand is on a mission to change the conversation around menopause. Every single woman goes through menopause, yet we still talk about menopause as if it’s a taboo medical condition. Women deserve frank conversation, high-quality education, and effective products to tackle the symptoms that come with peri- and post-menopause. Equelle aims to shift the conversation through an engaging community, high-quality educational resources, and, of course, science-backed products.

Uqora & Equelle are a subsidiary of Pharmavite (the owner of Nature Made), and together comprise Pharmavite’s women’s health business unit located in San Diego.

Inclusivity at Uqora & Equelle:

Diversity and inclusion is a priority for us. At Uqora, we’re committed to making our employees and community members feel seen, heard, and valued - while honoring what makes us different. We promise to remain focused on this journey of growth so we can become better advocates for our community, and we’d love for you to join us on that mission!

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APPLICATION FORM

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