Specialist, Quality Assurance Document Control

ABOUT US

At the heart of AG1 lies a commitment to our mission to empower people to take ownership of their health. Since 2010, we've dedicated ourselves to bringing Foundational Nutrition to people around the world.

Our ethos is deeply rooted in science, with an unwavering dedication to continuous improvement. We leverage and contribute to the latest research to deliver a powerful, straightforward solution for optimal health to our customers. We harness the finest ingredients so that every scoop of AG1 gives you the nutrients you need with the simplicity you want in a daily routine.

Likewise, our organization puts the same energy into creating an environment that is a reflection of the cultural values that define who we are and how we work together. These seven values— One Spectacular Life, Customer Centric, Radical Ownership, High Performance, Courage, Good Humans and Continuous Improvement—are a representation of the high standards we set, and hold ourselves accountable to, when it comes to building our global team.

THE ROLE

We are looking for a highly organized, collaborative, and self-motivated Specialist, Quality Assurance Document Control to join our best in class Quality & Product Safety team within AG1’s Supply Chain capability. This role will report to the Manager, Quality Systems and will be responsible for administering and maintaining AG1’s controlled documents, records, and the Quality Management document control system (QMS) in accordance with Title 21 CFR Part 11 Electronic Records, Title 21 CFR Part 111 Good Manufacturing Practices, and Title 21 CFR Part 101 Nutrition Labeling of Food.

The Specialist, Quality Assurance Document Control position is a critical role to ensure product and quality system documentation meets defined quality standards and worldwide regulatory requirements. Additionally, this position supports all documentation activities including review and release of deviations, change control requests, standard operating procedures, COAs and provides guidance to users of the document control processes and procedural training. The ideal candidate for this role is a humble, fast learner who is flexible and comfortable with multi-tasking while working together with cross-functional teams who are passionate about exceeding the needs of our customers.

WHAT YOU’LL DO

• Oversee all necessary documentation to maintain FDA 21 CFR 111 cGMP regulatory compliance and additional AG1 global requirements.
• Manage and maintain electronic Document Control Library (SOPs, Training Records, Finished Good & Raw Material COAs, etc.).
• Manage and meticulously control documentation related to the formulation of new products, ensuring accuracy and completeness.
• Maintain and control documentation for all 3rd party contract partners, including but not limited to partnerships, agreements, certifications, site assessments and registrations.
• Ensure accurate and full control of documents pertaining to product and ingredient claims substantiation.
• Maintain AG1 product library containing all first article, production samples, finished good products & inserts.
• Track and maintain vendor audit reports, customer product complaint data and finished good inspection reports.
• Maintain product retain sample data for bulk lots & finished good lots.
• Track Formula Deviations and BOM Changes.
• Track non-formula Deviations & Change Requests (Creation, tracking, issuance, & analysis).
• Support issuance of all Raw Material and Finished Goods Product & Packaging Component Specifications.
• Support issuance of all new Finished Product Label Review and updates.
• Track inventory destruction/ disposition records.

WHAT WE'RE LOOKING FOR

• Minimum science-related Bachelor’s Degree (biology, chemistry, etc.), or equivalent combination of education and experience required.
• A minimum of 3 - 5 years prior experience in Quality Assurance, Quality Control or Manufacturing is required: nutritional, dietary supplements, pharmaceutical or biotechnology experience is highly preferred.
• Highly skilled in document control lifecycle.
• Demonstrated knowledge of current Good Manufacturing Practices (cGMP) and Regulations for 21CFR and GxP.
• Detail oriented individual with high level of analytical ability to problem solve and create/find solutions utilizing an 'out-of-the-box' mindset.
• Ability to work in a fast-paced and evolving environment.
• Self-starter, able to work in matrix organization.
• Problem solving aptitude, with ability to create work-around methods for immediate use, and to initiate best-method processes for future implementation.

WHAT’S IN IT FOR YOU?

• Competitive compensation and performance-based incentive plans.
• A 100% remote working environment (excluding Laboratory positions), which has been implemented from day one.
• A strong company culture that is enforced through the hiring process to ensure values alignment and a highly collaborative team.
• A mission-driven approach to everything that we do, with an overall goal to significantly improve our customers’ health and wellness.
• A high-growth, dynamic environment with opportunities for your direct impact to be felt.
• Paid holidays, company-wide mental health days, and unlimited PTO (based on your country of residence).
• In-person team meetups for optimal collaboration, team building and accelerating productivity.
• A work environment and culture that is based on high performance, productivity and continuous improvement.
• The opportunity to work with passionate, high-growth, business-minded colleagues who bring their all to our mission each and every day.
• Access to AG1 products and branded swag.
• Monthly telecom stipend to offset some of the costs of home internet/wifi for eligible team members.
• All other benefits and insurances as required by law, based on your specific country of residence.

AG1 is dedicated to providing equitable and competitive compensation & benefits packages. For this particular role, the base salary range is $69,000 - $86,500 and will ultimately be decided at the offer stage, based on an individual candidate’s level of skills and experience aligned with the needs of this role. Base salary is only one component of total compensation for this position. We provide a competitive mix of base salary, performance bonus, and stock option allocation for eligible roles.

AG1 is an Equal Opportunity Employer. We are committed to inspiring fulfilling lives, starting with a focus on health and we believe this starts in the workplace. We do this by providing employees with a safe and welcoming work environment free of discrimination and harassment. We strive to create a diverse & inclusive environment where all team members can thrive, feel a sense of belonging, and make a difference in the world together. We do not discriminate based on age, race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, veteran status, disability, or any other status protected by law. We are an equal opportunity employer.