FULL TIME REMOTE Position: Quality Specialist Type of contract: Independent contractor Working Hours: M-F 🌎 Work from any corner of the world and be a part of the #remoteworkrevolution!‼️ About the Company Founded in 2017, this leading supplement brand quickly became the #1 probiotic on Amazon and is now distributed across more than 70,000 retail touchpoints, including Walmart, Target, CVS, and Sam’s Club. The mission is to empower individuals to make confident wellness choices, guided by medical expertise and backed by real results. The team thrives in a fun, health-conscious, and collaborative environment rooted in core values like Passion, Curiosity, Proactiveness, Resourcefulness, and Getting Sh@# Done. Scope of the Role The Quality Specialist ensures the Company’s quality program aligns with FDA regulations and internal quality standards. You’ll work across multiple departments and external partners to support product development, commercialization, and ongoing compliance for supplements that are safe, effective, and high-quality. Duties and responsibilities: Review Batch Records and Certificates of Analysis (COAs) for compliance and accuracy. Manage Retain Sample Reviews and oversee Product Release. Conduct Master Manufacturing Record (MMR) and Product Manufacturing Record (PMR) reviews. Manage Change Requests and document their implementation. Investigate and track Customer Escalations and Adverse Events. Submit Serious Adverse Events (SAEs) via the Safety Reporting Portal. Update Finished Product specification sheets. Coordinate with Contract Manufacturers on batch issues and sample testing. Requirements Requirements: Education and Experience Bachelor’s degree in Biology, Chemistry, Food Science, Nutrition, or related field. 1–3 years’ experience in a Quality role in cGMP or regulated environments. Experience in dietary supplements is a plus. Type of Experience Hands-on quality support in cGMP manufacturing environments. Familiarity with FDA regulations including 21 CFR parts 101, 111, and 117. Good Documentation Practices and Document/Records Control. Certifications like PCQI, HACCP, or Quality Auditor are preferred. Technical Skills Ability to interpret scientific and technical documents. Investigative skills related to quality complaints and adverse events. Understanding of label claims and formula input calculations. Proficiency in MS Office, databases, and project management tools.