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About the Role

The Quality Specialist is an essential member of the Quality Assurance team, responsible for maintaining the highest quality standards throughout the testing, release, and distribution of dietary supplements. This role requires a deep understanding and competency in 21 CFR Part 111 and 117. Key responsibilities include overseeing document control, change control, complaint management, tracking and trending adverse events and NCR/CAPA investigations to ensure compliance and product safety.

Responsibilities

Oversee QMS system processes, including document management, complaint management, CAPAs, non-conformances, training, and quality records.
Support the review, sign-off, investigation, trending, and escalation of adverse events and serious adverse events.
Track, analyze, and summarize quality data to support risk-based decision-making, continuous improvement, and management review.
Coordinate and track testing activities required for third-party certifications.
Maintain training matrices and training records.
Coordinate and facilitate employee training sessions.
Maintain controlled documents and ensure proposed changes are routed through the appropriate review and approval process.
Manage and monitor change control activities to ensure changes to products, processes, or documentation are appropriately assessed, approved, implemented, and documented.

Requirements

Minimum of a bachelor’s degree from an accredited four-year college or university in a related field, or an equivalent combination of education, training, and experience.
3+ years of relevant quality assurance experience in the food, dietary supplement, or related regulated industry.
Working knowledge of dietary supplement and food quality requirements.
Understanding of warehouse operations, manufacturing processes, and quality system requirements.
Experience using and managing activities within Veeva QMS or a comparable quality management system.
Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint, as well as Google Workspace tools.
PCQI certification or working knowledge of Preventive Controls requirements preferred.

Skills

QMS System Proficiency
Adverse Event Management
Data Trend Analysis
Third-Party Certification Testing
Training Management
Training Facilitation
Document Control
Change Control
Microsoft Office Suite
Google Workspace

Location

Austin, Texas

Work Type

Flexible workplace policy

Experience Level

3+ years of relevant quality assurance experience

Education Level

Bachelor's degree in a related field or equivalent combination of education, training, and experience
PCQI certification preferred

Benefits

Full medical, dental, and vision benefits
Basic Life Insurance
Immediate 401(k) eligibility with company matching
Unlimited vacation
Paid holidays
$100/month flexible benefit stipend
Tuition reimbursement
In-office meals
Product credits and discounts
Lifestyle spending account
Family planning
Online learning
Fitness stipend

About the Company

Onnit is a health and wellness company based in Austin, Texas, selling dietary supplements direct to consumers and through retail distribution.
We provide high-quality products with clinically studied ingredients designed to unlock a deeper mind-body connection and enhance both mental and physical performance.
We are part of the Wellbeing Collective, an exciting Global Business Unit within Unilever built with a start-up mindset.
Our mission is to improve the health and well-being of millions of consumers and continue leading in the Health and Wellness space.
We foster a culture that strives for Curiosity, Discipline, Approachability, Commitment, and Ownership Mindset.

Equal Opportunity

EOE race/color/religion/sex/sexual orientation/gender identity/national origin/disability/veteran status