Job Description

Description

BENEFITS OF BEING A GAIA HERBS EMPLOYEE

Gaia Herbs' meticulous dedication to quality extends well beyond the herbs we use in our products! We apply the same level of care in choosing the wellness programs, benefits, and other perks we provide to our employees. Here are some of the things that make Gaia Herbs a great place to work:

Generous PTO

Relax, recharge, and come back ready to take on anything.

Annual Wellness Week

Like spring break, but for grown-ups! Take a hike, and we’ll see you next week!

Paid Holidays

We’ve got you covered for all the big holidays

401K with Company Match

Plan for your future with our 401K, and a company match to boost your savings.

Premium Health & Dental

Top-tier coverage to keep you feeling your best – and keep you smiling about it!

Volunteer Time Off

Make a difference in your community, on our clock – doing good never felt so good.

Gaia Herbs Product Discounts

Fuel your wellness journey with discounts on our amazing products.

Exclusive Partner Discounts

Get great deals from our partner companies just because you’re a Gaian.

Free Organic Veggie Program

Enjoy fresh ROC certified organic veggies – Straight from our farm to your table.

On-Site Nurse Practitioner Visits

Health check? Check! Get expert care right at work without the hassle.

Free Quarterly Wellness Bundles

Let us hook you up with the best wellness products out there – on the house!  

Job Summary

The Quality Specialist is an onsite position in a dietary supplement manufacturing facility that includes raw material and production record review and approval, managing federal regulatory requirements for ethanol usage and reporting, managing the customer complaints process, assisting with conducting/closing investigations, leading quality projects, collecting & analyzing data, trending/reporting on quality metrics, SOP writing, and training on quality & regulatory related topics.

Essential Duties and Responsibilities

• Assisting with quality related tasks from raw material receipt to finished bulk production.
• Batch production initiation & review for multiple production processes.
• QC Laboratory test results review for raw materials and production batches.
• Back up for FQS (Floor Quality Supervisor), including performing quality monitoring tasks and responding to quality related events.
• Back up to Quality Inspector-Raw Materials for raw material review and approval.
• Assisting with non-conforming material reports and other reports.
• Managing TTB regulatory requirements under 27CFR part 17 at Gaia Herb’s headquarters in Brevard, North Carolina  
• This includes, but is not limited to:
• Track ethanol inventory.
• Processing monthly claims for excise tax rebates
• Submitting production formulas for TTB approval.
• Assisting in periodic internal audits of TTB practices to ensure compliance.
• Submitting required inventory documents for the use of denatured ethanol.
• Staying audit ready; supporting TTB audits.
• Authoring and reviewing TTB SOPs.
• Training personnel at all levels on TTB requirements
• Submitting various reports as needed.
• Ensuring all TTB regulations are met.
• Working collaboratively with other departments to improve and enhance TTB reporting structure and ensure compliance.
• Manage the product complaint and adverse event processes. 
• Document and investigate product complaints and adverse events.
• Submit all serious adverse events to FDA.
• Track and trend product complaints and adverse events.
• Collaborate with customer service on product complaint follow-up and training.
• Performing quality investigations and root cause analysis.
• Being a subject matter expert on Gaia’s production formulas and processes. 
• Preparing reports for various departments by collecting, analyzing, and interpreting data and summarizing trends. 
• Developing, reviewing, and updating SOPs and other technical documents.
• Assisting with CAPA related tasks.
• Developing and leading quality and regulatory related projects.
• Training personnel/departments on quality and regulatory topics (one on one & group settings)
• Mentoring co-workers with interpretation of regulatory requirements, procedures, or other guidance documents.
• Performing audits and completing audit reports; make recommendations and oversee follow up actions.
• Cooperating and collaborating in a spirit of assistance, order, professionalism, and mutual respect with members of management and staff.
• Conducting duties in compliance with all company policies and procedures.
• Other duties and responsibilities as assigned.

Requirements

Supervisory Responsibilities

None

Qualifications

Education and/or Experience

Required

• High school diploma or GED required. 
• Some college courses required (general English and Science) 
• Minimum 3 years’ experience working in Manufacturing, Quality Assurance or Quality Control. 
• Minimum of 1 year experience with FDA cGMP regulations.
• Intermediate knowledge of Microsoft Word, Excel, and PowerPoint

Knowledge, Skills, and Abilities:

• Some knowledge of QC Laboratory procedures.
• Ability to focus with strong attention to detail.
• Ability to understand basic production processes and equipment. 
• Ability to develop and understand flowcharts.
• Strong technical skills with the ability to learn new computer software and database systems. 
• Ability to prepare and use electronic databases/applications to record, track, and present information. 
• Superior personal organization skills, time management skills, and the ability to prioritize. 
• Superior written and verbal communication skills. 
• Critical thinking skills. 
• Intermediate knowledge of Microsoft Word, Excel, and PowerPoint. 
• Ability to adapt to new systems and processes. 
• Ability to read, write, and comprehend work instructions and other technical documents.
• Ability to write detailed investigations that laid out a clear series of events. 
• Ability to effectively present information in one-on-one and small groups situations to customers, clients, and other employees of the organization. 
• Auditing skills desired.
• Math and algebra skills. Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs. 
• Ability to positively interact with multiple functional areas quickly and effectively resolve quality related issues, ensuring schedules are maintained, and material is readily available. 

Computer Skills:

• Quality Management Systems 
• Microsoft Word, Excel, and PowerPoint
• ERP Systems
• Electronic Batch Record Systems

Physical Demands 

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to stand and walk. The employee is regularly required to sit; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl, talk or hear; and taste or smell. 

Work Environment

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually low. 

Equal Employment Opportunity has been, and will continue to be, a fundamental principle at Gaia Herbs, Inc., where employment is based upon personal capabilities and qualifications without discrimination based on race, color, religion, gender or gender identity, age, national origin, sexual orientation, physical or mental disability, veteran status, or any other protected characteristic as established by law. All employees and applicants will be treated fairly, with dignity and respect, in accordance with, and as defined by federal, state and local non-discrimination laws.