OLLY - Sr. Associate, Quality Assurance
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Requirements
• 3–5 years of Quality Assurance experience in a dietary supplement, food, consumer health, pharmaceutical, or other GMP‑regulated manufacturing environment; dietary supplement experience strongly preferred. • Working knowledge of 21 CFR Part 111 and/or 21 CFR Part 117, with familiarity in GMP, food safety, quality systems, and documentation control expectations. • Bachelor’s degree in Biology, Nutrition, Food Science, Regulatory Science, Chemistry, Microbiology, or a closely related science discipline; equivalent relevant experience may be considered. • Experience supporting or managing controlled documents, deviations, change controls, CAPA activities, product release support, COA/specification review, or quality records. • Ability to work independently, manage multiple priorities, meet deadlines, and follow through on open actions with minimal supervision. • Strong written and verbal communication skills, including the ability to write clear quality documentation and communicate quality decisions effectively. • Strong computer skills, including Microsoft Word, Excel, PowerPoint, databases, and enterprise systems; ERP or quality management system experience preferred. • Strong attention to detail, organizational skills, critical thinking, and problem‑solving abilities. • Experience working with external manufacturers, co‑packers, suppliers, contract laboratories, or third‑party logistics partners. • Experience with inventory disposition, quality holds/releases, product specifications, packaging instructions, finished‑goods documentation, or certification documentation. • Experience using ERP, PLM, document control, or electronic quality management systems. • Exposure to internal audits, supplier quality, complaint investigations, trend reporting, or inspection‑readiness activities. • Comfort working in a fast‑paced, growth‑oriented environment with evolving processes and cross‑functional priorities. • WHAT TO EXPECT DURING THE INTERVIEW PROCESS • Initial video screen with a member of our Talent team • Round 1: Conversation with the Hiring Manager + 1-2 conversations with other Ollies on the team • Round 2: 2-3 conversations with team or cross functional Ollies • Final Round: Homework* • At OLLY, our final round is called Homework. Candidates who participate in this round are given 3 questions in advance to answer and present to the interview panel they previously spoke with in the process. We understand every candidate is different. If you need a reasonable accommodation to adjust this procedure, please let us know as soon as possible so that we can evaluate and provide other options that work for your needs • THE DETAILS • LOCATION: Remote, USA
Responsibilities
• Quality Systems & GMP Documentation • Manage the routing, review, approval, issuance, and periodic updates of GMP‑controlled documents, including SOPs, work instructions, forms, quality manuals, and supporting records. • Author, revise, and review quality documentation to ensure alignment with OLLY requirements, applicable regulations, and current business processes. • Support document control practices to maintain accurate, inspection‑ready records and ensure appropriate version control, traceability, and retention. • Identify opportunities to simplify, strengthen, and standardize quality processes while maintaining compliance with internal and regulatory expectations. • Change Control, Deviations & CAPA Support • Facilitate change control records from initiation through implementation, including impact assessment, cross‑functional review, approval tracking, and closure verification. • Create, review, and/or approve deviations and quality events, as needed, to support daily operations and ensure timely documentation of nonconformances. • Partner with internal stakeholders and external manufacturing partners to support root cause analysis, corrective and preventive actions (CAPA), and effectiveness checks. • Track quality events and trends to help identify recurring issues, compliance risks, and opportunities for CAPA or process improvement. • Supplier, Co‑Manufacturer & Product Quality Support • Supplier, Co • Manufacturer & Product Quality Support • Support quality oversight of suppliers, co‑manufacturers, and co‑packers to ensure products and materials meet OLLY specifications, GMP requirements, and quality expectations. • Review and support disposition of inventory by confirming COAs against approved specifications and ensuring holds, releases, and inventory status updates are accurately reflected in the ERP system. • Coordinate material disposition forms, quality holds, releases, and related documentation with Operations, Supply Chain, Supplier Quality, and external partners. • Maintain and update finished‑goods QA manuals, packaging instructions, and other product‑specific quality documents. • Support complaint investigations in partnership with Supplier Quality and cross‑functional teams, including documentation review, trend monitoring, and escalation of potential product quality issues. • Operational Quality Execution • Support daily quality operations to ensure timely execution of QA deliverables for product release, documentation, samples, quality records, and certification programs. • Assist with the collection, review, organization, and maintenance of documentation and samples required for product certifications, customer requests, audits, and regulatory support. • Maintain quality databases, trackers, and shared records to support accurate reporting, traceability, and inspection readiness. • Provide practical quality guidance to business partners while balancing compliance requirements, business needs, and risk‑based decision‑making. • Cross‑Functional Collaboration & Continuous Improvement • Cross • Functional Collaboration & Continuous Improvement • Partner with R&D, Regulatory Affairs, Supply Chain, Operations, Supplier Quality, and external partners to maintain product specifications and ensure timely completion of QA activities. • Communicate quality requirements, risks, decisions, and next steps clearly to stakeholders at all levels. • Participate in cross‑functional problem‑solving and process‑improvement initiatives to strengthen quality systems and reduce recurring issues. • Contribute to a strong quality culture by demonstrating ownership, accountability, collaboration, and continuous improvement.
Benefits
• MANAGER: Senior Quality Compliance Manager • PLEASE NOTE: Candidates must be authorized to work in the United States without sponsorship. • An opportunity to work with an intelligent, inspiring, and extraordinarily fun team • We pay 100% of the premiums for employee-only medical, dental + orthodontics, and vision insurance • 4 weeks PTO + paid holidays + 12 Mental Health Days per year • 100% Paid parental leave, Fertility + Adoption Benefits • 401(k) plan with Employer Match • Hybrid Work + Wellness + Cell Phone Stipends
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